Complaint Investigation Questionnaires

Procedure 11774405 | Rev:12
Procedure (Non-PPE)
Complaint Investigation Questionnaires CO: 100520096
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COMPLAINT HANDLING & SAFETY SURVEILLANCE
COMPLAINT INVESTIGATION QUESTIONNAIRES
Purpose The purpose of this document is to describe the Cordis procedure to properly
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use the Complaint Investigation Questionnaires in order to assist with adequate
and appropriate investigation of events reported to Cordis Complaint Handling
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and Safety Surveillance department.
Scope The scope of this document pertains to all Cordis Complaint Handling and
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Safety Surveillance personnel responsible for complaint handling investigation.
This document does not encompass every complaint category or every event in
every category. It serves as a guide for investigation of high volume product
complaints. The questions can be used as a guideline when follow-up
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investigation is done via phone, or the questions can be e-mailed or faxed to the
appropriate complaint contact.
Definitions The table below defines specific terms used in this document
TR
Term Definition
Complaint Any written, electronic, or oral communication that
alleges deficiencies related to the identity, quality,
durability, reliability, safety, effectiveness or
NO
performance of a device after it is released for

distribution.
Event An adverse event or product malfunction or a
combination of adverse event and product malfunction
occurring with a device or devices during the same
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setting.
Global Complaint Database used for capturing and storing complaint
Handling System data.
(GCHS)
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Primary Data All source data and documents received from the
complainant or during the course of the complaint
investigation.
PR
Responsibilities The table below defines specific responsibilities for this procedure.
Position Responsibility
Analyst & Perform preliminary complaint investigation by
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Coordinator communicating with complainant or reporter. Review

complaint information received and use the
Investigational Questionnaires for guidance for
follow-up investigation of received complaints.
Documentation of follow-up investigation attempts
and responses in the GCHS.
Procedure (Non-PPE)
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Clinician Provide clinical input to ensure the appropriate level of
investigation. Assist analysts and coordinators with
the selection of questions within the Questionnaires
that are relevant to the reported Event. Obtain input
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from the risk assessment process that could impact the
questions required for appropriate event investigation
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and initiate revision of this guidance as appropriate.
CH&SS Manager or Provide the guidance and resources to comply with
designee this procedure. Verify all responsibilities are carried
out by CH&SS personnel and all guidelines are
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followed.
References External References:
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 ISO 13485:2016 Medical Devices – Quality Management Systems -
Requirements for regulatory purposes.
Internal Documents:
Document Type & Number
TR Document Title
Policy 11008 Complaint Handling Policy
Procedure 11010 Medical Device & Vigilance Reporting
NO
Procedure 10417127 Complaint Handling Procedure
Policy 23004 Records Management Policy
Procedure 10352733 Risk Assessment Procedure
Policy 10350888 Quality System – Compliance – Quality
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Assurance
Subordinate Documents: NA
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Requirements/ The table below defines specific actions required for use of the questions from
Procedure this guidance.
Task Activity
PR
1 Review all available Primary Data in the complaint file.

2 Review the Table of Contents of this guide and if available, choose
the Questionnaire that is relevant to the reported event.
3 Determine if additional information is required based on the
AP
available Primary Data as compared to the appropriate

Questionnaire. If additional information is required, select the
questions appropriate to the reported event(s) for which information
has not already been received. If the information has already
been provided, do not select the question.
4 After customizing the appropriate Investigational Questionnaire as
outlined in Task 3, perform follow-up communication with the
complainant or reporter with selected questions.
Procedure (Non-PPE)
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5 Document attempts to obtain additional information and all
responses in the complaint file.
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TABLE OF CONTENTS
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1. GENERAL NON-SERIOUS SIGNS & SYMPTOMS
2. HYPERSENSITIVITY
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3. PACKAGING COMPLAINTS
4. THROMBOTIC EVENTS – CARDIAC
5. MYOCARDIAL INFARCTION – CYPHER
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6. RESTENOSIS – CYPHER
7. DISSECTION / PERFORATION – CORONARY ARTERY
8. STENT FRACTURE
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9. STENT STRUT UPLIFT
10. RESISTANCE-FRICTION / IMPEDED / TRACKING DIFFICULTY / OBSTRUCTED -

SES / SDS / GW / CATHETERS / OUTBACK
NO
11. HUB LEAKAGE/CRACK – ANY PRODUCT THAT HAS A LUER HUB
12. BURST/LEAKAGE/INFLATION/DEFLATION/PREP/WITHDRAWAL DIFFICULTY –

BALLOON CATHETERS & STENT DELIVERY SYSTEM (SDS)
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13. SEPARATIONS -
SHEATHS / CATHETERS / BALLOON CATHETERS / STENT DELIVERY SYSTEM (SDS)
14. FRACTURE / SEPARATIONS - STEERABLE GUIDEWIRES
15. PRECISE & SMART SELF EXPANDING STENTS (SES) –

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PREPARATION / RESISTANCE-FRICTION-TRACKING / DEPLOYMENT DIFFICULTY / ADDITIONAL STENT

PLACEMENT / NEUROLOGICAL CHANGES / WITHDRAWAL DIFFICULTY
16. EXOSEAL
PR
17. VENA CAVA FILTER -

DEPLOYMENT DIFFICULTY / UNDEREXPANDED / MIGRATION / THROMBOSIS / FRACTURE
18. LUMEND CATHETERS - OUTBACK & FRONTRUNNER

AP
19. ANGIOGUARD EMBOLIC PROTECTION DEVICE

PREPARATION / RESISTANCE-FRICTION-TRACKING / DEPLOYMENT / CAPTURE OF FILTER BASKET /
NEUROLOGICAL CHANGES-ADVERSE EVENTS
20. EXPIRATION DATE EXCEEDED COMPLAINTS
21. AAA
22. Biopsy forceps
23. MYNX FAMILY

Procedure (Non-PPE)
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24. CREGANNA – FAILURE TO CROSS QUESTIONS
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GENERAL NON-SERIOUS SIGNS & SYMPTOMS
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Page 1 of 1
Cordis reference SR:

Product Name:
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Catalog Number:
Lot Number:
Study Name:
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PATIENT INFORMATION (REQUIRED DATA POINTS)
Age:
Weight (indicate lbs or kg):
Gender:
Medications:
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Allergies:
FACILITY / PRODUCT INFORMATION

NO
First Name, Last Name of contact at Site:
Date of contact for additional information:
What is the status of the device? (Discarded, Used for Training, Returned to manufacturer)?
If product will not be returned, provide a justification why the product is not available
If any questions are unknown or unavailable, provide a justification on why the additional information is
not available
ED
INDEX PROCEDURE (REQUIRED DATA POINTS)

 Admitting Diagnosis:
 Index Procedure Date (mm/dd/yy)
OV
 Was the Index Procedure Emergent or Elective?

 Was the Index Procedure Diagnostic or Therapeutic?
 Target Lesion Location:
 Target Lesion Characteristics:
PR
 Was the Lesion Pre-Dilated?

o Type and Size of Pre-Dilation Balloon:
Cordis Product(s) Used

Product name Catalog Number Lot number Maximum Deployment Pressure (if applicable)
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1.
2.
3.
4.
5.
 Lesion Post-Dilated?
o Type and Size of Post-Dilation Balloon
 Intra or Post Procedural Complications:
Procedure (Non-PPE)
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 Event Description:
 Event Date (mm/dd/yy)
 Treatment:
 Patient Outcome:
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 Other Comments:
 Was the reported event related to Cordis Product?
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 Was the reported event related to Non-Cordis Product?
 Was an alternative cause for the event provided, please explain.
EA
EL
TR
NO
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PR
AP
Procedure (Non-PPE)
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HYPERSENSITIVITY
Page 1 of 2
Product Name:
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Catalog Number:
Lot Number:
SE
Study Name:
MEDICAL HISTORY:
 Does the patient have a previous history of immunosupression / autoimmune disease? If yes please
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explain:
 Pre-admission/ Pre-procedure Medications?
 Allergies (food and drug)
 History of nickel, titanium or other metal allergy? Please specify
EL
INDEX PROCEDURE
 Index Procedure Date (mm/dd/yy) TR
 Was the index procedure Emergent or Elective?
 Target Lesion Location?
 Target Lesion Characteristics:
o De novo
NO
o In stent restenosis
o SVG
o Native vessel
o Bifurcation
o Calcified
o Angulated
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o Eccentric
o Concentric
o Ostial
o Tortuous (vessel)
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o Lesion type (A, B, C)

o Difficult to access or wire the lesion
 Was the site predilated prior to stent implantation?
o If predilated, at what inflation pressure?
o If predilated, what atmospheres?
PR
o If predilated, for how many seconds?

o What was the length and diameter of the predilation balloon

AP
Product name Catalog Number Lot number Maximum Deployment Pressure (if
applicable)
1.
2.
3.
4.
5.
Procedure (Non-PPE)
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HYPERSENSITIVITY
Page 2 of 2
 Was the stent post-dilated?
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o If post dilated, at what inflation pressure (atmospheres)
o If post dilated, for how many seconds?
o If post dilated, what was the length and diameter of the post dilation balloon?
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REPORTED EVENT
 Event Date (mm/dd/yy):
EA
 What was the hypersensitivity reaction?
 Was there a respiratory component? If yes, describe:
 List pre-procedural medications:
EL
 List intra-procedural medications:
 List post-procedural medications:
PATIENT OUTCOME: TR
 Did the reaction require admission to hospital?
 What was done to treat the reaction?
 What was the outcome of the treatment for the reaction?
 How long following the treatment did the reaction resolve?
 Was the reaction determined to be related to Cordis Product?
NO
 Was the reaction determined to be related to Non-Cordis Product?

 Was an alternative cause for the event provided?
 If the event was attributed to an alternative cause, please describe:
 Other Comments:
ED
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PR
AP
Procedure (Non-PPE)
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PACKAGING COMPLAINTS
Page 1 of 2
Product Name:
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Catalog Number:
Lot Number:
SE
Study Name:
DAMAGED/CONTAMINATION/COMPROMISED STERILITY
 Where was the reported packaging damage and the type of damage (indicate Yes to all that apply)?
o Damage to the Shipping Box
EA
o Damage to the Outer Product Box
o Inner Product Pouch:
 What type of damage was there? (indicate Yes to all that apply)
o Creased
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o Torn with Jagged Edges
o Clean Cut
o Seal Open
o Stain on the outside TR
o Foreign Material Inside
o Other - Describe:
 Was the integrity of the sterile pouch compromised?
 If the seal of the inner package was opened, is it possible that the product had been purposely opened in
anticipation of use, and when not used was reshelved?
NO
 When was the damage noted?

o Upon initial receipt of the product
o After it had been received, and stored in the lab, prior to using
 How was it stored in the lab?
 Was the actual product damaged?
ED
o If the product was damaged, please indicate the type of damage noted:
 Was the product used?
PACKAGING – LABELING MISSING/INADEQUATE/ILLEGIBLE
 Which label was affected
OV
o Outer Product Box (indicate below which part of the box)

 Spine
 Front
 Back
PR
 Bar Code Label

 Inner Product Pouch
 Fixed Label
 Bar Code Label
AP
 Indicate the Labeling Deficiency (indicate all that apply)

o Illegible Printing- Describe specifically which information was illegible (i.e. Product Code/Lot#,
expiration date, etc.)
- Indicate below why the information was illegible
 Stain – describe
 Missing Ink
 Smeared Ink
 Foreign Material – describe
 Other - describe
Procedure (Non-PPE)
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PACKAGING COMPLAINTS
Page 2 of 2
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 Missing Information? Indicate exactly what was missing:
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o Entire label
o Specific Information on the Label. Indicate what information was missing:
 Are pictures available? If so, please send.
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EL
TR
NO
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PR
AP
Procedure (Non-PPE)
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THROMBOTIC EVENTS – CARDIAC
Page 1 of 2
Product Name:
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Catalog Number:
Lot Number:
SE
Study Name:
GENERAL PATIENT AND PROCEDURAL QUESTIONS
 What was the patient’s admitting diagnosis?
 Was the patient admitted with an acute MI?
EA
 What medications was the patient currently taking at home?
 Was the procedure in which the Cypher was implanted an emergent procedure?
 What was the target lesion?
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 Were thrombolytics given? If Yes, specify which ones.
 Was there any pre-existing clot during the initial procedure?
 Was this a de novo lesion? If no, please explain.
TR
 Was the lesion inside a previously placed stent? If yes, what brand of stent?
 What were the lesion and vessel characteristics of the target lesion?
o Calcified
o Tortuous
NO
o Stenosis percentage %
o Acute angle
o Bifurcating
 Was more than one stent placed? If yes, how many?
 If more than one stent was placed, where in relationship to each other were they placed?
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o Were they overlapping?

 Was there difficulty in wiring or accessing the vessel during the initial procedure?
o If yes, were multiple wire used?
 Was the site pre-dilated prior to stent placement?
OV
o If pre-dilated, at what inflation pressure (atmospheres) and for how many seconds?
o What was the length of the pre-dilating balloon?
 What inflation pressure was used to deploy the stent & for how many seconds?
 What was the stent to vessel sizing?
PR
 Was there good wall apposition of the stent?

 Was there any indication of vessel dissection?
 Was the stent post dilated?
AP
o If post dilated, at what inflation pressure and for how many seconds?
o What was the length of the post-dilation balloon?
 Was there disease distal to the stent? If yes, was it treated? Please explain in detail.
 Was IVUS used after initial placement of the stent?
 How much heparin/Angiomax was administered?
 Were ACTs monitored during the procedure, and what was the ACT results?
Procedure (Non-PPE)
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THROMBOTIC EVENTS – CARDIAC

Page 2 of 2
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 Were Gp2b3a’s used? If yes, please provide name, and dosage.
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 What was the post-procedure regime of antiplatelet therapy?
 Was a loading does given? If yes, what dosage
 Was the patient compliant with the antiplatelet therapy?
EA
 What other medications was the patient prescribed upon discharge?
 What is the patient’s medical history?
o Diabetes
o Smoking
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o Family history of CAD
o High Cholesterol
o Hypertension TR
o Other
 Does the patient have a history of any blood clotting disorders? If yes, please explain.
 Is the patient immunocompromised? If yes, please explain.
 What date did the patient return with the restenosis/SAT?
NO
 What was the patient’s admitting diagnosis?
 What was done to treat the restenosis/SAT?
 What is the current status of the patient?
 What was the patient’s discharge diagnosis?
 Can we have a copy of the CD/films for the initial placement and for the return for thrombosis?
ED
o If so please send to
Complaint Handling & Safety Surveillance
14201 NW 60th Avenue
Miami Lakes, FL, 33014
OV
 Please provide any additional information relevant to the index procedure or related events.
PR
AP
Procedure (Non-PPE)
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MYOCARDIAL INFARCTION – CYPHER
Page 1 of 2
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Product Name:
Catalog Number:
SE
Lot Number:
Study Name:
GENERAL PATIENT AND PROCEDURE QUESTIONS
EA
 Provide patient’s medical history.
 What was the patient’s admitting diagnosis
 What were the patient’s admitting medications
 What is the patient’s medical history, please indicate below with yes below
EL
o Hypertension
o Diabetes
o Type (i.e. insulin dependant, oral medication, diet controlled)
o Smoking TR
o Clotting disorder
o Immunocompromised / Diagnosis
o Pregnant and/or lactating
o CABG
o Previous PCI
NO
o High Cholesterol
o Renal Impairment
o Hepatic Impairment
o Other
ED
 What were patient’s allergies pre procedure?

o Post procedure allergies if different from above
 Please comment on any relevant test or lab data.
 With regards to the initial Cypher stent implantation, what was the procedure date?
OV
 Was the patient admitted with an Acute MI or Acute Coronary Syndrome for the initial Cypher stent
placement?
 Where was the target lesion
 What was the length of the lesion(s)
 What was the diameter of the vessel (healthy area of treated lesion site)?
PR

o If predilated, at what inflation pressure?
AP

 Lesion Characteristics (please differentiate if more than one lesion)
o De novo
o In stent restenosis
o SVG
o Native vessel
o Bifurcation
o Calcified
Procedure (Non-PPE)
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MYOCARDIAL INFARCTION – CYPHER
Page 2 of 2
o Angulated
o Eccentric
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o Concentric
o Ostial
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o Tortuous (vessel)
 Were all the stents placed Cypher stents? If no, describe.
EA
 Were they placed in one vessel? Explain
 What inflation pressure was used to deploy the stent (atmospheres and how many seconds)

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Was there any possibility of dissection?
 Was any distal disease left untreated?
 Was “healthy tissue to healthy tissue” covered by the stent?
 Was the stent post-dilated? TR
 What was the residual % of stenosis after stent implantation?
 What was the TIMI Flow?
NO
o Pre stent
o Post stent
 How much Heparin /Agiomax was administered
o Bolus:
o Drip

ED
Were ACTS monitored in the case and what were they?

 Where GpIIBIIIa’s used?
o If yes, what brand & dosage and how administered (Bolus/Drip)?
 What other meds were given during the procedure?
 What other products were used in the procedure?
OV
 What was the patient’s status at discharge?

 What was the post procedure regime of antiplatelet therapy?
 Was the patient compliant with antiplatelet therapy?
 What other medications was the patient discharged on?
PR
 Date the patient returned with the restenosis?

 Where specifically was the restenosis located?
 What was done to treat the restenosis?
AP
 Can we have a copy of the procedure reports for the initial placement and the return for restenosis?
o Please return along with the questionnaire to
14201 NW 60 Ave
Miami Lakes FL 33014
 Name and number of implanting physician
 Name and number of the physician who performed the second procedure, if different
 Please provide any other information in narrative form:
Procedure (Non-PPE)
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RESTENOSIS – CYPHER
Page 1 of 2
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Product Name:
Catalog Number:
Lot Number:
SE
Study Name:

EA
 What was the patient’s admitting diagnosis
 What were the patient’s admitting medications
 What is the patient’s medical history, please indicate below with yes below
o Hypertension
EL
o Diabetes
o Type (i.e. insulin dependent, oral medication, diet controlled)
o Smoking
o Clotting disorder TR
o Immunocompromised / Diagnosis
o Pregnant and/or lactating
o CABG
o Previous PCI
o High Cholesterol
NO

o Renal Impairment
o Hepatic Impairment
o Other
 What were patient’s allergies pre procedure?
ED
o Post procedure allergies if different from above

 Please comment on any relevant test or lab data
 With regards to the initial Cypher stent implantation, what was the procedure date?
 Was the patient admitted with an Acute MI or Acute Coronary Syndrome for the initial Cypher stent
OV
implantation?
CYPHER STENT PLACEMENT:

 Where was the target lesion?
 What was the length of the lesion(s)?
PR
 What was the diameter of the vessel (healthy area of treated lesion site)?
 If predilated, at what inflation pressure?
AP

 Lesion Characteristics (please differentiate if more than one lesion)
o De novo
o In-stent restenosis
o SVG
o Native vessel
o Bifurcation
o Calcified
Procedure (Non-PPE)
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RESTENOSIS – CYPHER
Page 2 of 2
o Angulated
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o Eccentric
o Concentric
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o Ostial
o Tortuous (vessel)
EA
 Were all the stents placed Cypher stents? If no, describe.
 Were they placed in one vessel? Explain
 What inflation pressure was used to deploy the stent (atmospheres and how many seconds)
EL
 Was there any possibility of dissection?
 Was any distal disease left untreated?
 Was “healthy tissue to healthy tissue” covered by the stent?
TR
NO
 What was the residual % of stenosis after stent implantation?
 What was the TIMI Flow?
o Pre stent
o Post stent
 How much Heparin /Agiomax was administered
ED
o Bolus:
o Drip
 Were ACTS monitored in the case and what were they?
 Where GpIIBIIIa’s used? If yes, what brand & dosage and how administered (Bolus/Drip)?
OV
 What other meds were given during the procedure?

 What other products were used in the procedure?
 What was the patient’s status at discharge?
 What was the post procedure regime of antiplatelet therapy?
PR
 Was the patient compliant with antiplatelet therapy?

 What other medications was the patient discharged on?
 Date the patient returned with the restenosis?
 Where specifically was the restenosis located?
AP
 What was done to treat the restenosis?

 Can we have a copy of the procedure reports for the initial placement and the return for restenosis?
 Please sent to: Cordis Corporation
14201 NW 60 Avenue
 Name and number of implanting physician index and second procedure (if different)
 Please provide any other information in narrative form:
Procedure (Non-PPE)
Page 16 of 63
DISSECTION/PERFORATION – CORONARY ARTERY

Page 1 of 2
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Product Name:
Catalog Number:
SE
Lot Number:
Study Name:
EA
Index Procedure
 Admitting Diagnosis
 Index Procedure Date.
EL
 Was it an emergent or elective procedure?
 Target Lesion Location?
 Target Lesion Characteristics? TR
 Was the Lesion Pre-Dilated?
 Type and Size of Pre-Dilation Balloon and atmospheres
 Lesion Post-Dilated?
 Type and Size of Post-Dilation Balloon and atmospheres
NO

Product name Catalog Number Lot number Maximum Deployment Pressure (if
applicable)
1.
2.
ED
3.
4.
5.
OV
REPORTED EVENT
 Event Date (mm/dd/yy)
 Alert Date (mm/dd/yy)
PR
 Was there any difficulty tracking the stent deployment system through the coronary artery?
 Was there any difficulty crossing the lesion?
 What guide catheter was used?
 What guide wire was used?
AP
 What caused the dissection/vessel perforation?

 If a balloon rupture was the cause of the event, at what pressure did it rupture?
 What grade was the dissection (A, B, C, D, E, F)?
 Was the dissection flow limiting?
o If yes, what was the TIMI flow?
 Did the patient experience chest pain?
 Where there post-procedural ECG changes?
Procedure (Non-PPE)
Page 17 of 63
DISSECTION/PERFORATION – CORONARY ARTERY
Page 2 of 2
 Pre-procedural cardiac enzymes:
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o CK
o CKMB
SE
o Troponin
 Post-procedural cardiac enzymes:
o CK
o CKMB
o Troponin
EA
TREATMENT:
 What was done to treat the dissection/perforation?
EL
o Additional stent placement?
o Intra-aortic balloon pump?
o Balloon angioplasty?
o Pericardiocentesis?
o Other – please describe
TR
PATIENT OUTCOME:
 What was the resulting TIMI flow following treatment?
 Related to Cordis Product?
NO
 Related to Non-Cordis Product?
 Was an alternative cause for the event provided?
o If the event was attributed to an alternative cause, please describe:
 Other Comments:
ED
OV
PR
AP
Procedure (Non-PPE)
Page 18 of 63
STENT FRACTURE
Page 1 of 2
Product Name:
D
Catalog Number:
Lot Number:
SE
Study Name:
INDEX PROCEDURE:
 Was the stent originally placed in your facility?
 What was the target vessel / lesion?
EA
 Vessel Characteristics / Lesion morphology:
o Calcified
o Tortuous
o Stenosis percentage
EL
o Lesion length
o Chronic Total Occlusion (complete occlusion > 3 months)
o Bifurcation
o Angulated TR
 What was the total length of the stented segment?
 How many stents were initially placed?
 Did the stents overlap?
 What brand and size stents were used? Provide catalog and lot numbers for Cordis stents:
 Was the stent implanted in an actively moving segment of the artery?
NO
 Was the stented area in a location where the vessel was intramyocardial?
 Was myocardial bridging noted?
FOR BALLOON-EXPANDABLE STENTS:
 How many atmospheres of pressure were used to deploy the stent?
ED
 Was IVUS done after the initial stent placement?

 Were any anomalies noted?
o If yes, describe:
OV

Repeat Catheterization:
PR
 How was the fracture identified?

 Was the fractured stent completely separated?
 Was there any migration of the separated segment?
AP
Procedure (Non-PPE)
Page 19 of 63
STENT FRACTURE
Page 2 of 2
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 Was the stent fracture associated with any negative consequences?
o Restenosis?
SE
o Thrombosis?
o Flow limitations?
o Aneurysm?
 Was the fracture treated? If yes, describe treatment:
EA
 Is a procedural CD available for review?
 Please send to
EL
o Cordis Corporation
14201 NW 60 Avenue
Miami Lakes FL 33014 TR
NO
ED
OV
PR
AP
Procedure (Non-PPE)
Page 20 of 63
STENT STRUT UPLIFT
Page 1 of 1
Product Name:
D
Catalog Number:
Lot Number:
SE
Study Name:
PATIENT INFORMATION
 Age:
EA
 Weight (indicate lbs/kg):
 Gender:
 Medical History:
 Medications:
EL
 Allergies:
INDEX PROCEDURE
 Index Procedure Date (mm/dd/yy): TR
 Was the index procedure Emergent or Elective?
 What was the Target Lesion location?
 What were the Target Lesion characteristics?
 Was the lesion Pre-Dilated?
 Type and Size of Pre-Dilation Balloon
NO

Product name Catalog Lot number Maximum Deployment Pressure
Number (if applicable)
1.
2.
ED
3.
4.
 Did the stent appear normal prior to inserting it into the patient?
OV
o If not, describe the abnormality:

 Was any resistance experienced while passing the stent deployment system through the guiding catheter?
 Was any resistance experienced while tracking the stent deployment system to the lesion?
 Was any resistance experienced while crossing the lesion?
PR
 Was an attempt made to withdraw the stent deployment system with the stent on the balloon?
o If so, how many times was the system removed and reinserted?
 If the stent deployment system was withdrawn while the stent was on the balloon, was it pulled back
inside the guide catheter?
AP
 If the stent deployment system was withdrawn while the stent was on the balloon, were the guide catheter
and the stent deployment system removed as a single unit?
 If the stent deployment system was withdrawn, was any resistance experienced?
 Was excessive force applied to the device during insertion?
 Was excessive force applied to the device during withdrawal?
 What brand/size of guide catheter was used?
 Is the product going to be returned?
 What was the patient outcome:
 Other Comments:
Procedure (Non-PPE)
Page 21 of 63
HUB LEAKAGE/CRACK
Page 1 of 2
D
HUB LEAKAGE/CRACK
SE
When was the hub leakage/hub crack noted?
 Prior to insertion into patient
o During removal of device from package
o During flushing of the device
EA
o During connection of indeflator
 After insertion into patient
o During negative pressure
o During balloon inflation
EL
o During balloon deflation
INSPECTION AND PREPARATION OF THE DEVICE
 Were any anomalies noted when the device was taken out of the package?
 Was the device resterilized? TR
 Was the device pulled from the packaging by the hub and if so where any anomalies noted at this time?
 Was the device prepped following IFU instructions?
 Was any difficulty encountered flushing the SDS?
 Was any difficulty encountered connecting the hub to the indeflator device (if yes please explain)?
NO
 What is the manufacturer of the indeflator device?
 Were any anomalies noted during or after the device was prepped (please explain in detail)?
 Was the device used in the patient?
If hub leakage/hub crack was not noted during preparation or was used in the patient, please answer the
following questions
ED
DEVICE INSERTION
 What was the intended procedure/target lesion?
 Vessel / Lesion Characteristics
OV
o Was the lesion calcified (Severe, Moderate, Little or none, Unknown)?

o Was there vessel tortuosity (Severe, Moderate, Little or none, Unknown)?
o Vessel Angulation (Severe, Moderate, Little or none, Unknown)?
o What was the percentage of stenosis?
PR
o Was the device used for a Chronic Total Occlusion (total occlusion >3 months)?
 Was there any resistance advancing the product to the lesion?
 Was the device torqued or “steered” by the hub?
 Was the device advanced with the indeflator connected to the hub?
AP
 Were any anomalies noted after the device was delivered to the lesion?
DEVICE INFLATION/DEFLATION
 Were there any anomalies noted while pulling negative pressure?
o If so, describe if air bubbles were noted indicating leakage
o Indicate if there was any patient injury at this time
Procedure (Non-PPE)
Page 22 of 63
HUB LEAKAGE/CRACK
Page 2 of 2
D
 Were there any anomalies noted while inflating device with positive pressure?
o Indicate if the device was not able to be inflated at all due to anomaly.
SE
o Did the plunger depress into the syringe/indeflator when trying to inflate?
o Was the user unable to depress the plunger into the syringe/indeflator when trying to inflate?
o Indicate how many atmospheres were used to inflate the device before anomaly was noted?
o Indicate if the gauge of the indeflator indicated loss of pressure when anomaly was noted.
o Indicate if there was any patient injury at this time.
EA
 How many seconds was pressure maintained before anomaly was noted?
o Indicate if the gauge of the indeflator indicated loss of pressure while maintaining pressure.
 Was the stent fully deployed in the vessel?
o Was it deployed in the intended location (if not please explain in detail)?
EL
o Was post-dilation required due to the anomaly?
 Was the stent partially expanded but not deployed in the vessel?
o Was the device removed from the patient without complications (if not please explain)?
TR
 Was any additional intervention required due to anomaly (If yes please explain in detail)?
 Was the anomaly noted while deflating the device?
o Indicate how the device was deflated
NO
DEVICE WITHDRAWAL
 If the stent was not deployed in the vessel, how was the device removed from the patient
o By pulling the device inside of the guiding catheter
o Withdrawing the device and guiding catheter as a unit
 If the stent was not deployed in the vessel, was the device removed from the patient without
complication? (if not please explain)
ED
 Was additional intervention required to prevent patient injury?

 Was resistance met while withdrawing the device (please explain in detail)?
o From the vessel?
o Into the guide catheter?
OV
o Through the sheath or introducer guide?

PR
AP
Procedure (Non-PPE)
Page 23 of 63
RESISTANCE-FRICTION/IMPEDED/TRACKING DIFFICULTY/OBSTRUCTED -
SES/SDS/GW/CATHETERS/ OUTBACK
Page 1 of 4
D
Product Name:
SE
Catalog Number:
Lot Number:
Study Name:
EA
 Type of procedure:
 What was the target site?
 What was the access site? (Femoral, Radial, Other-Specify site):
EL
 Was the device prepped per the IFU?
 Was there any difficulty experienced in prepping the device?
 Was a contralateral approach used?
 Vessel Characteristics at target site: TR
o Calcified
o Tortuous
o Acute angle
o Bifurcating
NO
 Vessel Characteristics accessing target site:

o Calcified
o Tortuous
o Acute angle
ED
o Bifurcating
 Was the device being used for treatment of a chronic total occlusion?
 Did the device kink or bend at any time prior to the resistance/friction?
o Prior to Use
o During use
OV
o Noted on removal
 What concomitant device was the resistance/friction experienced with (Guidewire/CSI/Guide)?
o Brand and size of concomitant device
o Will concomitant device be returned with the complaint unit?
PR
 Did the other devices used with the product kink or bend at any time?
o Prior to Use
o During use
o Noted on removal
AP
 Was the insertion difficulty caused by a blockage of possibly injectable material?

 When was the difficulty encountered (indicate below all that apply)
o Advancement through another device
 Type of Device/Size/Brand (If Cordis product, provide catalog/lot information)
o Advancement over a Guidewire –
 Type of Device/Size/Brand (If Cordis product, provide catalog/lot information)
o Advancement through the vessel
o Withdrawal back into another device
 Type of Device/Size/Brand (If Cordis product, provide catalog/lot information
 Were other products successfully used with the device prior to the encountered resistance?
Procedure (Non-PPE)
Page 24 of 63
o Provide information on products used successfully
 Were other products successfully used with the device after the encountered resistance
 Provide information on products used successfully
 Had the product, or any of the other devices used with it been resterilized?
D
SE
RESISTANCE-FRICTION/IMPEDED/TRACKING DIFFICULTY/OBSTRUCTED –
Page 2 of 4
EA
 Did the difficulty require that:
o All concomitant products be removed together or
o Only the reported product was removed
EL
SES
 Was it verified prior to insertion that stent was contained within the outer sheath/introducer of the
system? TR
 Was the guidewire port flushed as outlined in the IFU prior to loading on the guidewire?
 What size sheath was used?
o Sheath brand (If Cordis product, provide catalog/lot information)
 What size Guidewire was used
o Guidewire brand (If Cordis product, provide catalog/lot information):
NO
 What size Guide Catheter was used

o Guide Catheter Brand (If Cordis product, provide catalog/lot information)
 What size Microcatheter was used?
o Microcatheter Brand (If Cordis product, provide catalog/lot information)
ED
SDS
 During prep, was the stent manipulated?
o If yes, please explain:
 Was the stent properly mounted on the system when inspected prior to use?
OV
 Was the SDS prepped according to IFU guidelines?

o If no, please explain?
 What size sheath was used?
o Sheath brand (If Cordis product, provide catalog/lot information)
PR

o Guidewire brand (If Cordis product, provide catalog/lot information):
 What size Guide Catheter was used
o Guide Catheter Brand (If Cordis product, provide catalog/lot information)
 Prior to inserting the SDS in the catheter, was the balloon inflated or partially inflated?
AP
 Was the negative pressure applied to the SDS?

 Was the inflation device in the neutral position when the system was being advanced/withdrawn?
 If the difficulty was encountered during withdrawal after stent placement:
o Was it confirmed that the balloon was fully deflated prior to withdrawal?
o Was negative pressure maintained on the inflation device during withdrawal of the system?
 Was the unexpanded or partially expanded stent pulled back into the Guide Catheter?
 Was the Guide Catheter repositioned by advancing or withdrawing over the stent?
Procedure (Non-PPE)
Page 25 of 63
D
Page 3 of 4
o Diagnostic Catheter – Size
SE
 Brand (If Cordis product, provide catalog/lot information)
o Microcatheter – Size
o SDS
EA
o Outback
o Other – Type/Brand (If Cordis product, provide catalog/lot information)
 Did the difficulty occur while the devices were being preloaded outside of the patient?
EL
 If the difficulty occurred during insertion into another device where in that device did the difficulty
occur?
o At the insertion point
o Proximal shaft TR
o Mid shaft
o Distal shaft
 Did the difficulty require that:
o All concomitant products be removed together?
OR
NO
o Only the reported product was removed?
 Was an adequate continuous flush maintained through all devices?
CATHETERS
 Was there difficulty tracking through the vasculature?
ED
 If the resistance/friction occurred with another device, what type of device and what was the size of the
other device?
o Introducer Sheath - Size
OV
o Guide Catheter - Size

o Diagnostic Catheter – Size
o Microcatheter – Size
PR

o SDS - Size
o SES – Size
AP

o Other (please describe)
Procedure (Non-PPE)
Page 26 of 63
Page 4 of 4
D
OUTBACK
 Was there any damage to the Outback device noticed prior to opening the package? If yes, provide
SE
details.
 Were all the specified ports of the device properly flushed?
 Were the ports flushed, followed by a 30 second delay, and then flushed again?
 Was cannula action verified during prep?
EA
o Brand (If Cordis product, provide catalog/lot information)
 If the difficulty was encountered with the GW, how far did the GW go before resistance was met?
 Was the device straight prior to loading?
EL
 Was the GW ultimately loaded successfully?
 If the loading difficulty was resolved, how was this accomplished? (indicate all that apply)
o continuous actuation
o by straightening the device TR
o by flushing the device a second time
o by wiggling the tip/device
 Was the needle/cannula fully retracted prior to insertion of the wire?
 Did the cannula actuate smoothly?
 Was the guidewire kinked or bent?
NO
 Was there any damage to the guidewire when the product was removed (i.e. sheared, frayed)
 Was the guidewire used previously in the procedure?
 How experienced was the physician with the using the device? The tech? Approximate number of cases?
 Was the sales rep present at the procedure?
 Was the procedure successfully completed?
ED
OV
PR
AP
Procedure (Non-PPE)
Page 27 of 63
BURST/LEAKAGE/INFLATION/DEFLATION/PREP/WITHDRAWAL DIFFICULTY
BALLOON CATHETERS & SDS
Page 1 of 2
D
Product Name:
Catalog Number:
SE
Lot Number:
Study Name:
 Provide the patient’s medical history
EA
o Was the lesion calcified?
o Was there vessel tortuosity?
EL
DEVICE PREPARATION & GENERAL USE TR

 Was there any difficulty removing the product from the hoop?
 Was there any difficulty removing the protective balloon cover
 Was there any difficulty removing the stylet or any of the sterile packaging components?
 Were kinks or other damages noted prior to inserting the product the product into the patient?
NO
 Did the device prep normally (i.e. maintain negative pressure)?
 What contrast media are you using (Brand and Manufacturer)?
 What was the contrast to saline ratio?
 What type and brand of inflation device was used (Indeflator/Syringe)?
 Was the same indeflator used successfully with other devices?
ED
 Was there any resistance/friction while inserting the balloon through the rotating hemostatic valve
 Was there any resistance/friction while inserting the balloon through the guide catheter?
o Was the lesion calcified?
o Was there vessel tortuosity?
OV

 Was there difficulty advancing the balloon catheter through the vessel?
 Was there difficulty crossing the lesion?
PR
 Was the catheter ever in an acute bend?

 Did the plunger depress into the syringe/indeflator when trying to inflate?
 Was the user unable to depress the plunger into the syringe/indeflator when trying to inflate?
 Did the balloon inflate normally?
AP
o If no, was leakage noted from the balloon, shaft, hub, or Unknown segment?
 What was the maximum inflation pressure?
 Did the balloon maintain pressure during inflation?
o If pressure was not maintained:
 Did the balloon burst?
 Did the shaft burst?
 Did the balloon deflate normally?
o If deflation was not normal:
 How long did it take to deflate the balloon?
Procedure (Non-PPE)
Page 28 of 63
 Did not deflate at all
 How was the balloon eventually deflated?
D
BURST/LEAKAGE/INFLATION/DEFLATION/PREP/WITHDRAWAL DIFFICULTY
BALLOON CATHETERS & SDS
SE
Page 2 of 2
 Did the balloon seem to “stick” to a stent (if being used for post-dilation)?
o If yes, what brand / type of stent?
EA
 Did the balloon re-wrap properly?
 If the balloon did not deflate or re-wrap properly, how was the balloon catheter removed?
 Did the balloon catheter kink while being used?
 Was the balloon catheter removed easily:
EL
o From the vessel?
o From sheath?
o From the RHV (rotating hemostatic valve)?
o From the guidewire? TR
o From the guide catheter?
 If the balloon catheter did not remove easily, how was it removed?
 If there was resistance/friction with other devices, which device(s):
o Type / Brand:
o If Cordis product provide catalog/lot information:
NO
 Was the product removed intact (in one piece) from the patient?
o If no: how was the separated segment removed?
 Did any patient injury occur?
o If yes, please describe:
o How was the injury treated:
ED

 Is the physician’s dictated summary and procedure log available?
 If requested by Clinician: Is a procedural CD available for review?
OV
PR
AP
Procedure (Non-PPE)
Page 29 of 63
SEPARATIONS - CATHETERS/BALLOON CATHETERS/SDS
Page 1 of 2
D
Product Name:
Catalog Number:
SE
Lot Number:
Study Name:
GENERAL PATIENT/PROCEDURAL QUESTIONS
EA
 Provide the patient’s medical history
o Was the lesion calcified (Severe, Moderate, Little or none, Unknown)?
EL
o Was there vessel tortuosity (Severe, Moderate, Little or none, Unknown)?
o Vessel Angulation (Severe, Moderate, Little or none, Unknown)?
TR
 Was the device resterilized?
 What part of the device separated:
o Hub
o Strain relief
o Hypotube
NO
o Shaft
o Balloon
o Distal tip
 Were any anomalies noted when removed from the package?
 Were any anomalies noted during prep?
ED
 Was the device inserted through a stopcock instead of a hemostatic valve.

 Was the device used in the patient?
 Did the device separate inside the patient?
o How was the segment retrieved?
OV
 Snare
 Surgery
 Unknown
PR
 If requested by Clinician: Is a procedural CD available for review?

o Please send to
Cordis Corporation
AP
14201 NW 60 Avenue
FOR HUB SEPARATIONS:

 Was the device pulled from the packaging by the hub?
 Was the device torqued or “steered” by the hub?
Procedure (Non-PPE)
Page 30 of 63
SEPARATIONS – SHEATHS/CATHETERS/BALLOON CATHETERS/SDS
Page 2 of 2
FOR STRAIN RELIEF SEPARATIONS:
D
 Was the device kinked or twisted under the strain relief?
SE
FOR HYPOTUBE SEPARATIONS:
 Was resistance met while advancing the device?
 Did the device kink in the area of separation?
 Approximately how far from the distal end did the device separate?
EA
FOR SHAFT/DISTAL TIP SEPARATIONS:
 Was resistance met while advancing the device?
 Was excessive torquing required?
EL
 Was resistance met while advancing the device over the guidewire?
 Did the device kink in the area of separation?
 Was resistance met while withdrawing the device?
TR
 Approximately how far from the distal end did the device separate?
FOR BALLOON SEPARATIONS:

 Was the balloon caught in the lesion?
 Was the balloon caught in a deployed stent?
NO
 Was resistance met while withdrawing the device?
 From the vessel?
 Into the guide catheter?
 Through the sheath or introducer guide?
 Through the rotating hemostasis valve?
ED
FOR SHEATH SEPARATIONS:

 Was there any difficulty or resistance (please explain if yes) during:
o prep
OV
o Insertion of dilator
o Insertion over the wire
o Removal of dilator
 Was there any resistance during withdrawal of any of the devices through the sheath?
 Was the separation related to any resistance during withdrawal of the sheath from the vessel?
PR
 Had the sheath kinked or been twisted/torqued prior to the separation?

 Did the separation occur during procedural use or was the sheath left in place post procedure & then
separated when removed at a later date/time?
 If it occurred during removal after post procedural use:
AP
o How long was the sheath in place?

o Was an obturator used in the sheath after the procedure?
o Was the sheath used for any infusions?
Procedure (Non-PPE)
Page 31 of 63
FRACTURE/SEPARATIONS – STEERABLE GUIDEWIRES
Page 1 of 2
D
Product Name:
Catalog Number:
SE
Lot Number:
Study Name:
 Was the product resterilized?
 Was the wire removed from the dispenser by the distal floppy end?
EA
 Was the wire kinked or damaged in any way prior to insertion into the patient?
 Was the wire re-shaped by the user?
 If the wire was re-shaped, what method was used?
 Was the wire used for treatment of another lesion prior to the event?
EL
 Vessel Characteristics
o Calcified
o Tortuous
o Stenosis percentage TR
o Bifurcating
 Was the lesion a Chronic Total Occlusion (100% occlusion for > 3 months)?
 Was a “drilling” or “jack-hammer” technique used to recannulize the vessel?
 When in the procedure did the event occur?
 Was the wire tip visible on fluoro throughout the procedure?
NO
 Was there difficulty tracking the wire through the vessel or lesion?
 Did the wire behave “normally” (was the torque response good)?
 Was there resistance/friction between the wire and other devices?
o During insertion?
o During withdrawal into another device?
ED
 If there was resistance/friction with other devices, which device(s)

o Type / Brand? (If Cordis product, provide catalog/lot information)
 Did the wire kink while being used?
 Was the wire advanced through the struts of an existing stent?
OV
 Did the wire tip repeatedly prolapse during placement?

 Did the tip remain in a prolapsed position during treatment of the lesion?
 Was the wire tip advanced into the distal vasculature?
 If the procedure was for treatment of a bifurcation lesion:
PR
o Was the wire used in the main vessel or side branch?

o Was the wire jailed at any time behind a stent?
 Did the wire become fixed or caught at any time prior to the event?
o During advancement?
o During withdrawal?
AP
 Did the wire become fixed or caught at any time:

o In the lesion?
o In distal vessel?
 Was the wire torqued against resistance?
 Was the wire removed intact in one piece from the patient?
 If the wire separated, how was the separated segment removed?
o Snare
o Surgery
o Other (explain)
Procedure (Non-PPE)
Page 32 of 63
FRACTURE/SEPARATIONS – STEERABLE GUIDEWIRES

Page 2 of 2
D
SE
 Is the physician’s dictated summary and procedure log available?
 Is a procedural CD available for review?
o Please send to
Cordis Corporation
EA
14201 NW 60 Avenue
EL
TR
NO
ED
OV
PR
AP
Procedure (Non-PPE)
Page 33 of 63
PRECISE & SMART SES – PREPARATION/RESISTANCE-FRICTION-
TRACKING/DEPLOYMENT DIFFICULTY/ ADDITIONAL STENT
PLACEMENT/NEUROLOGICAL CHANGES/WITHDRAWAL DIFFICULTY
Page 1 of 3
D
Product Name:
SE
Catalog Number:
Lot Number:
Study Name:
EA
 Was the temperature exposure indicator on the pouch checked to confirm that the black dotted pattern
with a grey background is clearly visible?
EL
 Was the product stored and handled according to the IFU?
 Was the product inspected and prepped according to the Instructions for Use?
 Was anything unusual noted about the stent delivery system prior to use?
TR
 Was the intended lesion located at the carotid bifurcation?
 What was the target lesion vessel diameter?
 What size sheath introducer was used?
 Who manufactured the sheath introducer?
NO
 What size-guiding catheter was used?
 Was the diameter of the unconstrained stent size 1-2 mm larger than the vessel diameter?
 What was the target lesion vessel length?
 What was the % stenosis of the target lesion?
 Was the lesion calcified?
o To what degree?
ED
 Was the vessel tortuous?

o To what degree?
 Did the stent delivery system pass through any acute bends?
 Was delivery of the SDS to the lesion Ipsilateral or Contralateral?
OV
 Was any difficulty encountered while advancing/tracking the SDS towards the lesion?
 Was any unusual force used at any time during the procedure?
 Was thrombus present proximal to, at, or distal to the lesion site?
 Was the lesion pre-dilated prior to stent implantation?
PR
o If yes, what balloon and size was used?

o At how many atmospheres?
 What was the percent stenosis after pre-dilation?
o What type of contrast was used?
AP
o What was the contrast mixed with?

o What was the ratio of contrast to fluid?
 Was any difficulty or resistance noted while crossing the lesion with the stent?
 Did the SDS have to pass through a previously placed stent?
 Did the stent expand fully with good wall apposition?
 Was the lesion post-dilated after stent implantation?
o What was the percent stenosis after post-dilation?
Procedure (Non-PPE)
Page 34 of 63
Page 2 of 3
D
 Was any thrombus noted post deployment?
SE
 Does the user think that the event was related to the stent?
 Does the user think that the event was related to the procedure?
DEVICE PREPARATION
EA
 Was the device prepped in the tray (Precise only)?
 Was the Tuohy Borst (hemostasis) valve in the open or closed position when received (Precise only)?
o All RX systems (5 and 6F) are packaged with the hemovalve open.
o For OTW, the 5.5F system is packaged with the hemovalve open, and the 6F system is package with
EL
the hemovalve closed.
o PRO RX is packaged in the open position.
 Was the Tuohy Borst valve closed prior to removing the device from the tray (Precise only)?
 When removed from the tray was the stent still constrained within the outer member/sheath?
TR
 Was a stopcock connected to the y-connector of the Tuohy Borst valve?
 Was any difficulty encountered flushing the stopcock?
 Was any difficulty encountered flushing the SDS?
NO
RESISTANCE/FRICTION, TRACKING DIFFICULTY
 What size and make of guidewire or embolic protection device was used?
 Was there any difficulty advancing the SDS over the guidewire or embolic protection device?
 Where did the difficulty occur, the tip, the hub, in the body/shaft?
 Did the guidewire/embolic protection device get stuck in the catheter and was unable to be removed, or
was it able to be withdrawn from the catheter?
ED
DEPLOYMENT DIFFICULTY
 Was the Smart Control locking pin in place during advancement towards the lesion?
 Was the locking pin removed before attempting to deploy the Smart Control stent?
OV
 Was the SDS advanced past the lesion and then withdrawn back into the lesion prior to stent deployment?
 The IFU instructs the user to hold the handle of the Smart Control SDS flat and straight outside the
patient. Was this done?
 Did the user (Precise) maintain a fixed inner shaft position during deployment?
PR
 Was any unusual force applied during deployment of the stent?

 How much of the stent had been pre-maturely deployed?
o Was any attempt made to re-capture it?
o How was it removed?
AP
 Were the tantalum markers (Smart Control) observed to open symmetrically?

DEPLOYMENT OF MORE THAN ONE STENT
 Were additional stents placed?
 Were they placed proximal or distal to the first stent?
 Was there any overlap?
 How many millimeters?
 If placed distal, was there any difficulty crossing the previously deployed stent?
Procedure (Non-PPE)
Page 35 of 63
Page 3 of 3
D
 Was there any difficulty or resistance during deployment?
SE
 Did the additional stent expand fully with good wall apposition?
EA
NEUROLOGICAL CHANGES/ADVERSE EVENTS
 Does the patient have any known allergies to Nitinol, nickel or titanium?
EL
 Did the patient have any neurological symptoms prior to the procedure?
o If yes, please list them.
 What size sheath introducer was used?
 Was there a tight seal between the SDS and the Toughy Borst (hemostasis) valve of the sheath introducer/
TR
guiding catheter during aspiration?
 Did the user aspirate prior to contrast injections?
 Were air bubbles noted at any time during the procedure?
 Was any thrombus noted pre-deployment?
NO
 Was an Angioguard Embolic Protection Device used?

 Was the Angioguard in place when the adverse event occurred?
 Did the patient exhibit any signs or symptoms of an adverse event?
o Describe any signs or symptoms.
o At what point did they occur?
ED
 Had the Precise stent been deployed when the adverse event occurred?
 Was any intervention or treatment provided to treat the event?
 What was the diagnosis of the adverse event?
 Did the symptoms fully resolve?
OV
 When did the symptoms resolve?

 Were there residuals?
o What were the residuals?
WITHDRAWAL DIFFICULTY/SEPARATION
PR
 If any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath
marker contacts the catheter tip and withdraw the system as one unit. (Do not remove guidewire.) Was
this technique followed?
 For a separated/dislodged stent was any attempt made to recapture the stent?
AP
o If so, how?
 Was the stent successfully removed?
 Did any piece of the stent or the stent delivery system remain in the patient?
Procedure (Non-PPE)
Page 36 of 63
EXOSEAL
Page 1 of 3
Catalogue Number:
Lot Number:
D
Please answer each question as appropriate. Provide additional details as requested.
SE
General Procedural/Patient Questions
1. Did the procedure use an antegrade or retrograde approach?
2. Was the Exoseal VCD used in a diagnostic or interventional procedure?
3. What was the patient’s approximate height and weight?
EA
4. Had the physician achieve certification on the use of Exoseal VCD?
a. How many times has the physician used the Exoseal VCD prior to this procedure?
5. Was the Exoseal VCD prepped according to IFU instructions?
6. Were there any visible signs of device/package damage prior to use?
EL
a. If yes, please describe damage:
7. How many Exoseal devices were used in this patient?
8. Which catheter sheath introducer was used? (if Cordis sheath, please indicate lot and catalog numbers).
a. Arterial site (s) - Manufacturer ___________ Model _________French size _______
TR
b. Venous site - Manufacturer ___________ Model _________French size _______
9. Information regarding the puncture femoral site:
a. Was femoral artery’s suitability verified on angiography, including the insertion angle (30-
45 degrees) of the vascular sheath introducer?
b. Was the vessel diameter verified to be greater than or equal to 5mm in diameter?
NO
c. Did the puncture site have visible calcium/plaque?

d. Was there a stent near the puncture site?
e. Did the vessel have stenosis >50% at or near the puncture site?
f. Was the target femoral site previously closed with any closure device or manual
compression less than 30 days prior to this procedure?
ED
g. Was there evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at

the access site prior to Exoseal VCD use?
10. Information regarding the use of the Exoseal VCD?
a. Was resistance/friction experienced as the Exoseal VCD was advanced through the sheath?
b. Was there difficulty connecting the vascular sheath introducer with the Exoseal VCD?
OV
c. Was there any difficulty deploying the plug?

d. Was hemostasis successfully achieved with the Exoseal VCD?
PR
Select applicable questions below according to the reported product experience:
11. Was resistance/friction experienced as the Exoseal VCD was advanced through the sheath?
a. Was the sheath kinked/bent?
b. Was the angle of access between 30 and 45 degrees?
AP
c. Was the vascular sheath introducer rotated 180 degrees before trying to re-advance the
Exoseal VCD?
d. Was excess force applied during insertion?
e. What was the patient’s weight?
f. Was the Exoseal VCD and vascular sheath introducer removed and manual compression
used to achieve hemostasis?
12. Was there difficulty connecting the vascular sheath introducer with the Exoseal VCD?
a. Was the vascular sheath introducer retracted until the hub engaged with the Indicator Wire
Cowling?
Procedure (Non-PPE)
Page 37 of 63
EXOSEAL
PAGE 2 OF 3
D
b. Did the vascular sheath introducer lock against the Handle Assembly and an audible click
SE
heard?
i. Which catheter sheath introducer was used? (if Cordis sheath, please indicate lot
and catalog numbers).
Manufacturer ___________ Model _________French size _______
ii. Was the Exoseal VCD pulled out of the sheath and another Exoseal VCD used?
EA
iii. Was the Exoseal VCD and vascular sheath introducer removed and manual
compression used to achieve hemostasis?
iv. Other (please describe):
c. Was there pulsatile flow observed from the Bleed-Back Indicator?
EL
i. Was the Bleed-Back Indicator visibly damaged?
ii. Which catheter sheath introducer was used? (if Cordis sheath, please indicate lot
TR
iii. Was the Exoseal VCD and vascular sheath introducer removed and manual
compression used to achieve hemostasis?
13. Was there any difficulty deploying the plug?
a. Was the Exoseal VCD and vascular sheath introducer retracted together until pulsatile flow
significantly slowed or stopped from the Bleed-Back indicator?
NO
i. Did the pulsatile flow never stop?

ii. Did the pulsatile flow initially stop but then returned?
b. Was the Exoseal VCD and vascular sheath introducer retracted together until the Indicator
Window changed to solid black color?
i. If not, did the physician have the thumb placed on the Plug Deployment Button
ED
during retraction?
ii. Did the Indicator Window show any red color during retraction?
iii. Was the Exoseal VCD securely locked with the vascular sheath introducer?
c. Was the Deployment Button fully depressed and flushed against the handle?
i. Was the Indicator Window showing solid black at this time?
OV
ii. Was excess force needed to fully depress the button?

iii. Did the button depress half way only?
iv. Was the button stuck and could not be depressed at all?
d. Was the Exoseal VCD and vascular sheath introducer removed as a single unit from the
PR
patient approximately 1-2 seconds after depressing the Deployment Button?

i. Did the plug fall out of the Exoseal VCD shaft upon removal from the patient?
ii. Was the plug found partially deployed, half way out of the shaft?
iii. Was the plug found fully inside the shaft?
e. Was there any suspicion of the plug being deployed intravascularly?
AP
i. Did the patient show any signs and symptoms of distal blood flow occlusion?
Please describe:
ii. Was the patient treated to restore distal blood flow?
Please describe:
Procedure (Non-PPE)
Page 38 of 63
EXOSEAL
PAGE 3 OF 3
iii. Are procedural films available?
D
Please mail to:
Cordis Corporation
SE
Attn: Complaint Handling & Safety Surveillance Department
14201 NW 60th Avenue
Miami Lakes, Florida 33014
United States
14. Was hemostasis successfully achieved with the Exoseal VCD?
EA
a. Was there PULSITILE bleeding of the puncture site immediately noted upon removal of
the Exoseal VCD and sheath?
i. Was there only oozing of the puncture site easily treated with light pressure?
ii. Were there multiple stick attempts made before arterial access was achieved?
EL
iii. How was the pulsatile bleeding treated? (manual pressure, pressure dressing,
patch, fem stop, other).
iv. Did the patient develop a hematoma immediately after the plug was deployed?
v. How was the hematoma treated?
TR
vi. Which catheter sheath introducer was used? (if Cordis sheath, please indicate lot
b. Did the puncture site start bleeding during the patient’s recovery at hospital / at home?
i. How long after plug deployment did the bleeding start approximately?
NO
ii. What was the patient’s blood pressure?

iii. Was the patient anticoagulated? ACT?
iv. What was the patient’s activity when the bleeding started?
v. Was the patient diagnosed with a hematoma, pseudoaneurysm or retroperitoneal
bleed?
ED
vi. How was the bleeding/patient treated?

OV
PR
AP
Procedure (Non-PPE)
Page 39 of 63
VENA CAVA FILTER
Page 1 of 2
Product Name:
D
Catalog Number:
Lot Number:
SE
Study Name:
GENERAL QUESTIONS
 Indication for filter insertion (DVT, PE, Prophylactic)?
EA
 How was PE/DVT documented diagnosed?
 What was the extent of the DVT?
 Was thrombus present at delivery site?
 Anticoagulation therapy:
EL
 Contraindication for anticoagulation?
 Recurrent PE in spite of anticoagulation?
 Was pre/post imaging completed?
 Size and shape of the vena cava? TR
 Size measured or estimated?
 Peri/post procedural complications?
 Was there patient injury?
 How long after placement did the event occur?
NO
 Intervention to correct the reported event?
 Films available?
o If so please forward to:
Cordis Corporation
Building 8C
ED
14201 NW 60 Avenue
DEPLOYMENT DIFFICULTY
OV
 Vessel characteristics
 Any acute bends or tortuosity? (including access site)
 Any difficulty or resistance/friction while advancing the deployment sheath to the deployment target?
 Any difficulty or resistance/friction while advancing the filter to the deployment target?
PR
 Did the obturator remain fixed while the deployment sheath was pulled back over the obturator?
 Was it verified under fluoroscopy that the filter was not in a side vessel?
 Are procedural films available?
o If so please forward to:
AP
Cordis Corporation
14201 NW 60 Avenue
Procedure (Non-PPE)
Page 40 of 63
VENA CAVA FILTER
Page 2 of 2
UNDEREXPANDED
 Had the thermal indicator been activated?
D
 Was it verified under fluoroscopy that the filter or part of the filter was not in a side vessel?
 Was the entire filter under expanded or only part of it?
SE
o If only part of it, which part?
 Vessel characteristics
o Any acute bends, tortuosity, calcification, thrombosis or stenosis?
 Was wall apposition deemed adequate to prevent migration?
EA
 Are procedural films available?
o If so please forward to: Cordis Corporation
EL
14201 NW 60 Avenue
MIGRATION
 Had the thermal indicator been activated? TR
 If an OptEase was used, was it verified prior to deployment that the hook was caudal?
 Was there complete wall apposition on all sides post deployment?
 Was the filter deployed without tilt?
 Where was the original filter placement?
NO
 Was there a large or excessive thrombus load?
 Anti-coagulation therapy provided?
 Was the filter fractured?
 How far and where did the filter migrate?
 Was CPR administered? Was the patient put into Trendelenburg position?
 Was the patient given any increased amounts of fluids, either orally or IV prior to the migration?
ED
THROMBOSIS
 What was the indication for filter placement?
 Was the patient taking any “blood thinners”, anti-platelet medications, IIB3A’s etc?
OV
 Did the patient have any history of DVT or blood clotting disorders?
 Where was the initial filter placement?
 What was the location and size of the thrombus load?
 Anti-coagulation therapy provided?
PR
 Did the thrombus resolve?
FRACTURE
 Were there any delivery problems?
AP
 What are the vessel characteristics?

 Was the filter ever in an acute or sharp bend in the delivery tube while it was out of the storage tube?
 Where was the filter placed?
 Was there an associated filter migration?
 Was CPR administered? Did the patient have any chest traumas?
 Describe the location and number of fractures.
 Did the fracture occur during deployment, during post-dilation, or on follow-up exam?
Procedure (Non-PPE)
Page 41 of 63
OUTBACK / FRONTRUNNER
Page 1 0f 2
Product Name:
D
Catalog Number:
Lot Number:
SE
Study Name:
GENERAL QUESTIONS:
 Was the device prepared as specified by the instructions for use?
EA
o Was there any apparent damage to the device noticed prior to use?
o Were all specified ports flushed?
o Were the ports flushed, followed by a 30 second pause, and then flushed again?
o Was heparinized saline used for preparation and flushing of all ports?
EL
o Was cannula actuation (Outback) or distal tip (Frontrunner) action verified outside of the patient?
o Was the catheter held in a straight orientation, with “no slack” during preparation?
 Was the catheter coiled at any point prior to insertion?
 Was there an adverse event associated with the use of this device?
TR
o Was intervention required to treat the adverse event?
o If yes, what was done?
o What were the results?
o Was there patient injury?
o Is the patient stable?
NO
 Does the physician believe the Outback/Frontrunner caused the event?
QUESTIONS SPECIFIC TO OUTBACK LTD COMPLAINTS (OTB42120)

 Was the catheter prepped in the straight configuration?
 Was the cannula tip fully retracted before insertion?
ED
o Was the handle deployment slide locked in the proximal position?

 During prep did the cannula/needle actuate smoothly?
o Was there any difficulty retracting the cannula back into the catheter?
 Was there a one to one response to the nosecone while rotating the Rotating Hemostatic valve during
OV
prep?
 What was the type, brand, and diameter of the guide wire used?
 Was there any difficulty advancing the Outback over the guidewire?
 If there was trouble loading a guide wire with the Outback LTD:
PR
o Was an approved guidewire used for the procedure?

o How was the guidewire loaded? (backloaded or frontloaded?)
o How far did the guidewire advance before resistance was met?
o How would you describe the resistance? Was the resistance grainy/gritty (rough), frictional (as though
the wire was too large), or was there an outright blockage (stoppage)?
AP
o Was the guidewire ultimately loaded successfully?

 If the issue with guide wire loading was resolved, how was this accomplished?
o With continued actuation?
o By straightening the device?
o By preparing or flushing the device a second time?
o By “wiggling” the tip/wire interface?
Procedure (Non-PPE)
Page 42 of 63
OUTBACK / FRONTRUNNER
Page 2 0f 2
 Was proper orientation confirmed under fluoro prior to actuation of the cannula?
D
 Was there any difficulty advancing the Outback to the lesion?
 While torquing the device during placement, did the user hold onto the black handle or the clear plastic
SE
hub?
o If the device was held from the clear plastic hub, please indicate why?
 Did the user encounter resistance when torquing the device?
o If so, please describe the amount and type of resistance.
EA
 Did the device make a "clicking sound" and then begin to turn freely while torquing?
 Did the user hold onto the luer hub assembly located in front of the black handle while torquing the
device?
 Was the tip stuck in the lesion while torquing?
EL
 Was there any difficulty/resistance actuating the product?
 Was the “L” marker leg, on the catheter “LT” directional marker band, towards the target re-entry site
verified using an initial fluoroscopic view?
 Was the stored torque in the catheter shaft released after the cannula tip was properly positioned?
TR
 Was the “LT” directional marker band slot oriented toward the desired vascular location (target site) prior
to actuation of the handle deployment slide?
 Once at the lesion did the cannula/needle actuate smoothly?
 Was the physician able to re-enter the vessel with the guidewire?
 Was there resistance or difficulty removing the Outback from the patient?
NO
 Was abnormal force required?

 Was the cannula retracted prior to catheter withdrawal?
QUESTIONS SPECIFIC TO FRONTRUNNER COMPLAINTS (FBS3990):

 Was there difficulty operating (opening/closing) the distal tip (jaws)?
ED
 Was there difficulty moving the handle? Did it move too freely?
 Was the distal tip fully closed before insertion?
 Was the distal shaft shaped? If yes, what device was used to shape it?
 Was the proximal port flushed per the IFU?
OV
 Was the catheter wiped down or emerged in heparinized saline prior to use?
 Was excessive force required to advance the catheter?
 For dislocation of the actuating jaws, was there a complete separation into two or more pieces? Or did
they remain attached to the actuator wire?
PR
 Was there a break in device integrity other than the actuating jaws, leading to separation into two or more
pieces?
 Was difficulty experienced when removing the product from the patient? From the vessel? Through
another device?
AP
 Was the handle closed or the catheter torqued while withdrawing from the lesion?
 Was the Catheter “LT” Directional Marker Band in the correct position on the device? Was it easily
viewed under fluoroscopy?
QUESTIONS SPECIFIC TO FRONTRUNNER COMPLAINTS (FBS3990):

 How long and with what frequency has the physician been using OUTBACK?
 Have the physician’s technique been impacted by any changes in indications, thought leadership or
publications?
 What was this patient’s ischemic disease burden? (Rutherford classification)
Procedure (Non-PPE)
Page 43 of 63
Category 0: Asymptomatic
Category 1: Mild claudication
Category 2: Moderate claudication
Category 3: Severe claudication
D
Category 4: Rest pain
Category 5: Minor tissue loss; Ischemic ulceration not exceeding ulcer of the digits of the
foot
SE
Category 6: Major tissue loss; Severe ischemic ulcers or frank gangrene
 What were the patient’s underlying co-morbidities that made you select percutaneous intervention as first
EA
line therapy vs surgical options?
 If percutaneous intervention was not available to you, which surgical intervention would you have
recommended for this patient?
EL
 What was the target vessel?
 What was the approach, ipsilateral or contralateral?
 What was the presentation of the patient’s anatomy?
a. Calcified access site? TR
b. Iliac Bifurcation (calcified?, steep angle?, please describe)
Ancilliary products Used and device preparation
 What sheath did you use, short or long (brand and size)?
NO
 Did you use a Guide Catheter to insert the Outback? Brand
 Was an approved guidewire used for the procedure? Brand
 Was the Outback prepped following IFU instructions?
 During prep did the cannula/needle actuate smoothly?
 Did any ancillary devices show damage after the procedure? (ex. GW unraveled/kinked/ stretched, GC or
ED
sheath damaged)
Insertion and Withdrawal of Outback

1. Was placement or manipulation of any of the ancillary devices (sheath, GW, GC) problematic
OV
during the procedure?

2. Was there any difficulty advancing the OUTBACK over the guidewire?
3. Was there any difficulty advancing the OUTBACK over the iliac bifurcation?
PR
a. Was the “L” marker leg, on the catheter “LT” directional marker band, towards the inferior
direction when advancing over the horn?
4. If the OUTBACK was able to be delivered passed the iliac bifurcation,
a. Was there any difficulty getting to the target lesion?
AP
b. Was there any difficulty actuating or retracting the cannula at this point?
c. Was the guide wire delivered successfully passed the lesion?
d. Was the lesion treated successfully?
5. Was abnormal force required anytime during the procedure? If so,
a. Was the force in axial movement or torquing of the OUTBACK?
b. When in the procedure was the abnormal force noted?
c. Did the application of that force coincide with:
i. Advancing the device
Procedure (Non-PPE)
Page 44 of 63
ii. Torquing the device
iii. Interaction with ancilliary devices
iv. Actuating the needle inside the patient
v. Withdrawing the device
D
6. Was there resistance or difficulty removing the OUTBACK from the patient?
SE
EA
EL
TR
NO
ED
OV
PR
AP
Procedure (Non-PPE)
Page 45 of 63
ANGIOGUARD EMBOLIC PROTECTION DEVICE
Page 1 0f 3
Product Name:
D
Catalog Number:
Lot Number:
SE
Study Name:

EA
 Was the ACT maintained greater than 300 while the Angioguard was deployed?
 Was the product stored and handled according to the IFU?
 Was the product inspected and prepped according to the Instructions for Use?
 Was anything unusual noted about the device prior to use?
EL
 Was the intended lesion located at the carotid bifurcation?
 What was the target lesion vessel diameter?
 Was the Angioguard sized larger than the vessel as instructed in the IFU?
TR
 Did the device pass through any acute bends?
 Was any difficulty encountered while advancing/tracking the device towards the lesion?
 Was any unusual force used at any time during the procedure?
 Was thrombus present prior to, at, or after the lesion site?
 Was the lesion pre-dilated prior to stent implantation?
NO

 What was the percent stenosis after pre-dilation?
 What type of contrast was used?
o What was the contrast mixed with?
ED
o What was the ratio of contrast to fluid?

 Was any difficulty or resistance noted while crossing the lesion with the device?
 Did the device have to pass through a previously placed stent?
 Did the filter basket expand fully with good wall apposition?
OV

 Does the user feel that the event was related to the Angioguard?
PR
 Does the user feel that the event was related to the procedure?
GUIDEWIRE DEVICE PREPARATION

 Was the device prepped according to the IFU?
AP
 Upon opening the package, was the deployment sheath tip still fully seated in the filter basket introducer?
(large, hard, clear plastic piece containing the expanded filter basket).
o If not, was it manually inserted into the filter basket introducer?
 Was any difficulty encountered flushing the filter introducer and deployment sheath?
o Was saline noted within the coil dispenser at the green deployment sheath hub?
 Was the torque device locked onto the guidewire?
 Was the anti-migration clip located closest to the filter introducer left in place until after the filter basket
was docked into the deployment sheath?
Procedure (Non-PPE)
Page 46 of 63

Page 2 0f 3
D
 While docking the filter basket into the deployment sheath was any difficulty encountered.
 NOTE. When completely docked, approximately half of the filter basket will still be visible out of the end
SE
of the deployment sheath.
 Was the proximal end of the deployment sheath in contact with the torque nut prior to removing the
device from the coil dispenser?
 Was the capture sheath coil dispenser flushed according to the IFU?
EA
RESISTANCE/FRICTION, TRACKING DIFFICULTY
 Was there any difficulty advancing the device?
 Where did the difficulty occur?
EL
 Was excessive torque used during advancement or delivery of the Angioguard?
 Did the Angioguard get stuck in the catheter and was unable to be removed, or was it able to be
withdrawn from the catheter?
TR
 Was the hemostatic valve fully opened prior to insertion of the Angioguard?
DEPLOYMENT
 Was sufficient space allowed between the lesion and the filter basket to prevent interaction between
devices?
NO
 Were both proximal and distal markers positioned distal to the lesion being treated?
 Was complete deployment of the filter basket confirmed under flouro?
 Were the marker bands on the filter struts fully opposed to the vessel wall?
 Was the hemovalve closed after filter basket deployment?
 Was dye injected to confirm adequate blood flow through the filter basket?
ED
CAPTURE OF THE FILTER BASKET

 Was there any difficulty advancing the capture sheath to the lesion?
 During filter retrieval, is the retrieval sheath being advanced while the filter wire is fixed?
 Was there filter basket deformation?
OV
 Was force required for withdrawal of the filter prior to the marker band dislodgement or filter
deformation?
 During the procedure, was the filter distal enough from the lesion to prevent any interaction from the
Balloons/SDS used?
PR
 Was there any interaction between the filter basket proximal markerband and the distal end of other
devices used for the procedure?
o If so what interaction? “hammering”, “touching”, “impact”, etc.
 Was the capture sheath advanced until the marker band lined up with the proximal filter basket marker
AP
band?
 Did the filter basket collapse into the capture sheath as evidenced by a reduction in filter basket diameter
shown by the radiopaque strut markers?
 Was there any difficulty capturing the filter basket into the capture sheath?
 Was there any debris in the filter basket after removal?
 Did the user feel that any debris from the filter basket escaped during withdrawal?
 Was the filter basket suctioned prior to being withdrawn into the capture sheath?
o What technique/device was used?
Procedure (Non-PPE)
Page 47 of 63
Page 3 0f 3
 Was the Angioguard successfully removed?
D
o If difficulty was encountered while removing the device, what technique was used to resolve the
difficulty?
SE
NEUROLOGICAL CHANGES/ADVERSE EVENTS
 Does the patient have any known allergies to Nitinol, nickel or titanium?
 Did the patient have any neurological symptoms prior to the procedure?
EA
o If yes, please list them.
 Was any thrombus noted pre-deployment?
 Did the patient exhibit any signs or symptoms of an adverse event?
EL
o Describe any signs or symptoms.
o At what point did they occur?
 Was the Angioguard in place when the adverse event occurred?
 Had the stent been deployed when the adverse event occurred?
TR
 Was any intervention or treatment provided to treat the event?
 What was the diagnosis of the adverse event?
 Did the symptoms fully resolve?
o When did the symptoms resolve?
 Were there residuals?
NO
o What were the residuals?

ED
OV
PR
AP
Procedure (Non-PPE)
Page 48 of 63
EXPIRATION DATE EXCEEDED COMPLAINTS
Page 1 0f 1
 Please verify the date the stent was implanted?
D
 Please verify the Use by date indicated in the outer product box
 Please verify the Use by date indicated in the inner product package
SE
 What was the target vessel?
 When was it realized that the product had an exceeded Use by date:
 During inventory control/stock
 During the procedure but before opening the outer box or inner package
EA
 During the procedure, but before use/implantation inside the patient
 After the product was used/implanted in the patient
 Other (please specify):
EL
 Was there any issue affecting the integrity of the Outer Product Box and/or the inner
package that impeded legibility of Use By date section/expiration date (i.e. stained,
damaged/torn, creased)?

TR
Was the printing of the date indicated in the Use by section illegible for any reason? Please
specify (i.e. smeared ink, missing numbers, no date indicated).
 How is product inventory managed? Please provide details

 First in first out (FIFO) / Last in first out (LIFO)?
NO
 How does your facility manage inventory product that is near expiration or has expired (i.e.
internal inventory system, with sales representative, LINK analyst*). Please describe:
 What is your current practice regarding recording expiration date of an implantable product
during a procedure?
 Was there is a specific circumstance that led to this incident of using an expired product?
ED
(key personnel on vacation, new personnel, not used to this particular product, hectic
schedule, etc.)
 If the event was attributed to an alternative cause, please describe:
OV
For Cypher only, ask these two additional questions:
 When are Cypher units typically set aside?

 Prior to expiration
PR
 On first day after expiration

 Left with inventory until Cordis pick-up
 Other, please explain
AP
 Were there any specific circumstances regarding the process used in your facility for Expired
Cypher product in this particular month that contributed to usage of the expired Cypher
stent? Please describe:
Procedure (Non-PPE)
Page 49 of 63
AAA
Page 1 0f 4
D
Study Name:
SE
Patient Information
Admitting Diagnosis:
Index/Follow-up Procedure Date (mm/dd/yy):
Was the Index/Follow-up Procedure Emergent or Elective:
EA
Age:
Weight (indicate lbs or kg):
Gender:
Medications:
EL
Allergies:
Medical History:
Anticoagulation therapy:
Provide Details of the Event

Vessel Characteristics
TR
 Aneurysm size, type, location:
 Neck characteristics (angulation, diameter and length):
 Access site:
NO
 Presence/amount of thrombosis in aortic landing zone:

 Presence/amount of thrombosis in iliac artery landing zone:
 Presence/amount of thrombosis in supra-renal zone:
Products
ED
Cordis AAA Product(s) Used

Product name Catalog Number Lot number
1.
2.
OV
3.
4.
5.
 How experienced was the physician with the using the device: Approximate number of cases:
PR
 How experienced was the technician with the using the device: Approximate number of cases:
 Was the sales rep present at the procedure:
 Was the procedure successfully completed:
 Were there any adverse events:
 How long after placement did the event occur:
AP
 Was there any intervention to correct the reported event:

 Patient Outcome:
 Was the reported event related to a Cordis Product:
 Was the reported event related to the procedure:
 Was an alternative cause for the event provided, please explain.
 Are procedural films available:
 Were there any product malfunctions:
o Please explain in detail:
Procedure (Non-PPE)
Page 50 of 63
AAA
Page 2 0f 4
Device Preparation
D
 Was the temperature exposure indicator on the pouch checked to confirm that the black dotted pattern
with a grey background is clearly visible:
 Was the device stored and handled according to the Instructions for Use (IFU):
SE
 Was the device inspected and prepped according to the IFU:
 Was anything unusual noted about the device prior to use:
 Was there any damage to the device noticed after opening the package: If yes, provide details:
EA
 Was the Sheath Hemostasis Valve Screw Cap verified tight prior to use:
 Was any difficulty encountered flushing the guidewire lumen:
 Was any difficulty encountered flushing the prosthesis lumen:
EL
General Index Procedure Questions
 What size, shape and make of guidewire was used for ipsilateral access:
 What size, shape and make of diagnostic catheter was used:
 When was the diagnostic catheter withdrawn to a position just above the aortic bifurcation:
TR
 Was there any resistance/friction noted during pullback:
 Was the diagnostic catheter withdrawn over a guidewire:
 Was the delivery handle and delivery system shaft parallel with the patient’s leg during deployment:
 Was the bifurcate contralateral side marker aligned with the contralateral iliac artery:
 Did the bifurcate expand fully with good wall apposition:
NO
 Did the outer sheath maintain a fixed position when removing the bifurcate delivery system:
 Did the position of the graft edge markers remain fixed while retracting the sheath:
 Did the limb prosthesis expand fully with good apposition to the bifurcate legs:
 Was the device post-dilated after implantation:
o If yes, what balloon and size was used:
ED
o At how many atmospheres:

o Was the bifurcate fully expanded and apposed to the vessel walls after post-dilation:
o Was the limb prosthesis fully expanded and apposed to the bifurcate after post-dilation:
 Was any thrombus noted post deployment:
OV
 Were there any peri/post procedural complications, please explain in detail:

 Limb prosthesis only-was the cranial edge marker placed between the minimum and maximum overlap
markers of the bifurcate:
Inability to cannulate the contralateral leg

PR
 Was alternative imaging viewed to help determine actual guidewire positioning:

 Was contralateral guidewire positioning confirmed with a diagnostic pigtail catheter:
Resistance/Friction, Tracking Difficulty

AP
 Did the device pass through any acute bends:

 Was any difficulty or resistance encountered while advancing/tracking the device towards the aneurysm:
o If yes, at what point:
 Was any unusual force used to advance the device at any time during the procedure:
 Did the device kink or bend at any time prior to the resistance/friction:
 Did the device pass through a previously placed stent:
 Did the device get stuck on the wire and was unable to be removed, or was it able to be withdrawn from
the wire:
Procedure (Non-PPE)
Page 51 of 63
AAA
Page 3 0f 4
Pre-mature Deployment
D
 Did the device pass through any acute bends:
 Was any difficulty or resistance encountered while advancing/tracking the device towards the aneurysm:
SE
 Was any unusual force used to advance the device at any time during the procedure:
 How much of the stent had been pre-maturely deployed:
 When did it occur:
EA
 Was any attempt made to re-capture it and was it successful:
 Was it deployed in the correct location:
 How was it removed:
 Was there any vessel damage:
EL
Deployment Difficulty
 Was the device torqued while advancing through the sheath or towards the aneurysm:
o If yes, was it torqued by the handle body or the nose-cone:
TR
 Was the handle body rotated at any time prior to deployment:
 Was the bifurcate advanced past the renal arteries and then withdrawn back to a location even with or
lower than the lowest aspect of the renal arteries prior to stent deployment:
 Were the cranial graft-edge markers verified to be below the lowest renal artery aspect prior to
deployment:
NO
 Was the bifurcate contralateral side marker aligned with the contralateral iliac artery prior to attempted
deployment:
 Were the cranial graft-edge markers observed to open symmetrically:
 The IFU instructs the user to hold the delivery handle and delivery system shaft parallel to the patient’s
leg outside the patient. Was this done:
ED
 While deploying the bifurcate was one hand placed on the nose-cone to steady the device while the
handle body was rotated:
 Was any unusual force applied during deployment of the device:
 Did the position of the graft edge markers change while rotating the handle body:
 Did the trans-renal stent fully expand and symmetrically appose the vessel walls:
OV
 Was an attempt made to re-position the bifurcate:

o If so explain what happened (how much of the bifurcate had been exposed, was it re-
positioned cranial or caudal, was any resistance encountered, was there any damage to
vessel, etc.):
PR
Secondary Release
 Was the release wire secure in the torque device:
 Did the release wire pull smoothly or was there any resistance/friction noted:
AP
 If the release wire separated how was deployment completed:

 Did the trans-renal stent fully expand and symmetrically appose the vessel walls:
 Did the device graft material occlude any of the renal artery:
Deployment of the Limb Prosthesis

 Was it verified that the limb cranial edge marker was placed within the maximum and minimum bifurcate
overlap markers:
 Was it verified that the limb caudal edge marker was above the iliac artery opening:
 Was there any difficulty encountered while trying to cannulate the bifurcate contra-lateral limb opening:
Procedure (Non-PPE)
Page 52 of 63
AAA
Page 4 0f 4
Under-expanded
D
 Was it verified under fluoroscopy that the device was not in a side vessel:
 Was the entire bifurcate under expanded or only part of it:
SE
o If only part of it, which part:
 Was wall apposition deemed adequate to prevent migration:
Migration
 Was there complete wall apposition on all sides post deployment:
EA
 Was the device deployed without tilt:
 Was there a large or excessive thrombus load:
 Was the device fractured:
EL
 How far and where did the device migrate:
 Was CPR administered: Was the patient put into Trendelenburg position:
 Was the patient given any increased amounts of fluids, either orally or IV prior to the migration:
 Did the patient experience any additional interventions, i.e.: cardiac/peripheral percutaneous procedures:
TR
Thrombosis
 Was the patient taking any “blood thinners”, anti-platelet medications, IIB3A’s etc:
 Did the patient have any history of DVT or blood clotting disorders:
 What was the location and size of the thrombus load:
NO
 Anti-coagulation therapy provided:

 Did the thrombus resolve:
Fracture
 Were there any delivery problems:
ED
 Was the device ever in an acute or sharp bend:

 Was there an associated device migration:
 Was CPR administered: Did the patient have any chest traumas:
 Describe the location and number of fractures.
OV
 Did the fracture occur during deployment, during post-dilation, or on follow-up exam:
 Prosthesis Post-Dilated:
o Type and Size of Post-Dilation Balloon
PR
Withdrawal Difficulty/Separation
 Was any resistance met during delivery system withdrawal:
 For a separated/dislodged component was any attempt made to recapture it:
o If so, how:
AP
 Was the component successfully removed:

 Did any piece/component remain in the patient:
o What part of the device:
Procedure (Non-PPE)
Page 53 of 63
BIOPSY FORCEPS
PAGE 1 OF 1
Device preparation:
D
 How was the device removed from the tray? Vertical or horizontal motion?
 Was there an attempt to shape the shaft or the tip?
SE
Kinking:
 Please define when the kink occurred.
 Was the product actually kinked when the packaged was opened?
EA
 Was the product kinked as it was being removed from the package? If so please return the package in
addition to the device.
 Was the device removed in a vertical or horizontal motion?
 Was there an attempt to "shape" or "re-shape" the product?
EL
Dull Jaws:
 How many previous samples were taken in this setting of this "dull" jaws experience?
 Were the jaws "dull" from the onset of use? TR
 How many times has the heart been sampled in previous procedures?
Open/Close Difficulty with the Jaws:

 When was the “open/close” difficulty experienced?
 During prep?
NO
 During use in the patient?

 Was there any kinking in the body of the forceps?
 How many previous samples were taken in this setting of this "open/close" experience?
 Did the jaws function well initially and then fail, or was the issue present from the first attempt at use?
 Were the forceps rinsed between samples?
ED
Withdrawal Difficulty:
 Was there difficulty in withdrawing the device
o From the patient?
OV
o From the guide?

o From the CSI?
 Was there difficulty in opening and closing the jaws?
 Did the jaws open and close properly prior to entering the patient?
 Were the jaws able to cut the myocardial tissue?
PR
 How many previous samples were taken prior to the difficulty?

 Were the jaws rinsed between samples?
 Did the device kink during use?
 Had there been an attempt to reshape the product?
AP
 Other information:
Procedure (Non-PPE)
Page 54 of 63
D
SE
MYNX FAMILY
General Procedural/Patient Questions for Mynx product family.
EA
1. What type of procedure was the Mynx VCD used in (Choose an item: e.g. diagnostic peripheral,
diagnostic coronary, interventional peripheral, interventional coronary procedure or other)? If other,
please provide procedure type.
EL
a. Did the procedure use an ante-grade or retrograde approach?
2. What is the patient’s:
a. Age or Date of Birth? TR
b. Weight?
c. Height?
d. Gender?
NO
3. What is the deployer’s Mynx training status (e.g. Mynx certified, in training with the Mynx, not trained
to the Mynx device)?
4. Did the patient have any relevant medical history (e.g. bleeding disorder, hypertension, obesity,
previous surgical procedures, PVD, allergies, etc.)?
ED
5. Relevant tests/Laboratory data, include dates:

6. List other devices (include manufacturer name) associated with the procedure (e.g. stents, guide
catheter etc.):
OV
7. Concomitant Medical Products & Therapy Dates (e.g. anticoagulants etc.)

8. Sheath introducer information:
a. Sheath manufacturer?
PR
b. Model?
c. Sheath French size?
AP
If Cordis sheath was used, please indicate lot and catalog numbers:
9. Information regarding the puncture femoral site:
a. Was femoral artery’s suitability verified on angiography or venography (MynxGrip only), including
the insertion angle (30-45 degrees) of the vascular sheath introducer?
b. What was the vessel type? e.g. arterial or venous (MynxGrip)?
c. If the device was not used in the femoral artery or vein, what vessel was the device used in?
d. Was the vessel diameter verified to be greater than or equal to 5 mm in diameter?
Procedure (Non-PPE)
Page 55 of 63
e. Was there vessel tortuosity (Severe, Moderate, Little or none, Unknown)?
f. Where was the stick location? (for bleeding events and sealant misdeployment)
g. Was there presence of PVD / calcium in the vicinity of the puncture site?
D
10. How hemostasis was achieved (e.g. sandbag, FemoStop/mechanical device, manual compression,
another Mynx device, other manufacturer’s device)?
SE
a. If manual compression, provide duration if known or state if it was 30 minutes or less or greater
than 30 minutes?
EA
11. Was the patient hospitalized or was the patient's hospitalization extended as a result of the event?
a. If yes, how long was the hospitalization extended for?
12. What was the patient’s outcome/status after the Mynx event (e.g. recovered, recovering, not recovered,
EL
etc)?
MynxGrip Device Malfunctions:

TR
Failure mode: Sealant Exposed Prior to Use
1. How was the device removed from the package?
NO
2. Was the shuttle handle displaced?

3. Was the sealant sleeve out of position?
4. Was the sealant exposed during prep, while removing the device from package or during
ED
deployment?
Failure mode: Inability to Advance in Sheath

OV
1. Was the sheath kinked/bent upon removal?

2. Any visible bent/damage in distal end of the balloon shaft after removal?
3. Was excess force applied during insertion?
PR
4. Was the patient morbidly obese? (If weight and height were not provided in General
Procedural/Patient Questions.)
If yes:
AP
a. Was the angle of access between 30 and 45 degrees?

b. Was the patient’s BMI > 40 kg/m2?
Failure mode: Balloon Loss of Pressure

1. Was the Mynx VCD prepped according to IFU instructions? If no, please explain.
2. Did the balloon lose pressure during prep or patient use?
If the balloon lost pressure during patient use, please respond to the following questions:
Procedure (Non-PPE)
Page 56 of 63
3. Was there prior PTA, stent, or vascular graft in the common femoral artery or vein?
4. Did the balloon lose pressure upon inflation, at the 1st stop or 2nd stop?
5. Any visible damage in distal end of the sheath after removal?
D
6. Was there presence of PVD / calcium in the vicinity of the puncture site?
SE
Failure mode: Pull Through
1. Was the Mynx VCD prepped according to IFU instructions?
2. Did the balloon lose pressure? If yes see BLOP.
EA
3. Was the device purged of air during prep?
4. Was there scar tissue present in the vicinity of the puncture site?
EL
a. If yes, was excessive force applied?
Failure mode: Shuttle Advancement Issue
1. Was resistance/friction experienced as the Mynx VCD was advanced through the sheath?
TR
2. Was the sheath kinked/bent?
NO
If yes
4. Was the sealant stuck to device components? If yes
ED
a. Was the device storage temperature exceeded 25 °C?
Failure mode: Failure to Deploy/ Advancer Tube Not Present

OV
1. Did the user shuttled down completely?

a. Was there significant resistance when shuttling down?
b. Was unusual force applied when retracting the sheath?
PR
2. Was the advancer tube engaged or visible?
Failure mode: Device Deployment Jam

AP
1. Was the stopcock of the introducer sheath opened prior to shuttle down?
2. Was there significant resistance when shuttling down?
3. Was excessive force applied when shuttling down?
4. Was unusual force applied when retracting the sheath?
5. Were there any kinks in the sheath or device after removal?
6. Did the device storage temperature exceeded 25 °C?
Procedure (Non-PPE)
Page 57 of 63
Failure mode: Balloon retraction Jam/ Failure to Deflate

1. Was the balloon fully deflated?
D
2. Was the balloon prepped with 50/50 contrast, 100% saline or 100% contrast?
3. Was the deployer pinching/pinning the balloon with the advancer tube?
SE
4. Was the balloon inverted?
EA
Failure mode: Catheter /Balloon Detachment/Balloon Proximal Bond Separation
1. What part of the device separated? Balloon, Balloon Proximal Bond, Catheter or core wire?
2. Did the device separate inside the patient? If yes
EL
a. How was the segment retrieved? Snare, Surgery, Unknown, Other (if other, please explain)
*See questions for Balloon retraction Jam/ Failure to Deflate. These failures are usually the result of
excessive force applied to the device while withdrawing the balloon through the advancer tube.
Failure mode: Failure to Achieve Hemostasis

TR
1. Was there pulsatile bleeding of the puncture site immediately noted upon removal of the advancer
tube? If yes,
a. Was the sealant deployed to the proper location?
NO
2. Were anticoagulants, antiplatelets or any thrombolytics used? If yes, please provide name, and
dosage and what was the result?
3. What was the ACT during the procedure?
ED
4. What was the patient’s INR: >1.5?
Failure mode: Sealant stuck to device components

OV
1. Was the device storage temperature exceeded 25 °C?

2. What location did the sealant stick to (e.g. catheter, distal end of the shuttle, advancer tube distal
tip, balloon proximal tip)?
PR
3. How much sealant was stuck to the device component?

a. If a small amount was stuck, was the balloon fully deflated after shuttling down?
b. If a significant amount, was there over tamping?
AP
4. Did the deployer shuttle down completely?
Failure mode: Sealant Misdeployment / Sealant Exposed

1. Was sealant dislodged? (If the advancer tube is not held in place while removing the balloon from
the access site, the sealant may become dislodged from above the arteriotomy.)
2. Was the patient thin? Shallow vessel depth? (If weight and height were not provided in General
Procedure (Non-PPE)
Page 58 of 63
Failure mode: Sealant Misdeployment (intravascular)/ Occlusion

1. Was contrast/imaging used to confirm balloon placement?
D
2. Did the deployer fail to maintain tension on catheter while tamping?
3. Did the deployer over-tamp?
SE
4. Were there multiple sheath exchanges?
5. Was a procedural sheath that is greater than 7F used prior to introducing the Mynx?
6. Was the vessel < 5mm?
EA
7. What treatment was given to restore distal blood flow?
EL
Mynx Ace Device Malfunctions:
TR
Failure mode: Sealant Exposed Prior to Use
1. Was the sealant sleeve out of position?
NO
2. How was the device removed from the package?
3. Was the sealant exposed during prep or while removing the device from package?
Failure mode: Inability to Advance in Sheath

ED
1. Was resistance/friction experienced as the Mynx VCD was advanced through the sheath?
2. Was the sheath kinked/bent upon removal?
3. Was excess force applied during insertion?
OV
If yes
PR

AP
Failure mode: Balloon Loss of Pressure

1. Was the Mynx VCD prepped according to IFU instructions? If no, please explain.
2. Did the balloon lose pressure during prep or patient use?
If the balloon lost pressure during patient use, please respond to the following question:
3. Was there prior PTA, stent, or vascular graft in the common femoral artery or vein?
Procedure (Non-PPE)
Page 59 of 63
Failure mode: Pull Through
D
1. Was the Mynx VCD prepped according to IFU instructions?
2. Did the balloon lose pressure? If yes see BLOP.
SE
3. Was the device purged of air during prep?
4. Was there scar tissue present in the vicinity of the puncture site?
b. If yes, was excessive force applied?
EA
Failure mode: Button #1 stuck
EL
1. Did the button depress halfway only or could not be depressed at all?
Failure mode: Button #2 stuck TR

1. Did the button 1 depress halfway or could not be depressed at all?
2. Did the handle slide back all the way?
NO
Failure mode: Button #3 stuck
1. Were Button #1 and #2 activated before Button #3 was attempted?
ED
4. Did button 3 slide back halfway or could not slide at all?
Failure mode: Balloon retraction Jam/ Failure to Deflate

OV

3. Was the balloon inverted?
PR
Failure mode: Catheter /Balloon Detachment/ Balloon Proximal Bond Separation

1. What part of the device separated? Balloon, Balloon Proximal Bond, Catheter or core wire?
AP
2. Did the device separate inside the patient? If yes

a. How was the segment retrieved? Snare, Surgery, Unknown, Other (if other, please explain)
*See questions for Balloon retraction Jam/ Failure to Deflate. These failures are usually the result of
excessive force applied to the device while withdrawing the balloon through the advancer tube.
Failure mode: Failure to Achieve Hemostasis

Procedure (Non-PPE)
Page 60 of 63
1. Was there pulsatile bleeding of the puncture site immediately noted upon removal of the device? If
yes,
b. Was the sealant deployed to the proper location?
D
3. What was the patient’s INR? >1.5?
SE
dosage and what was the result?
EA
Failure mode: Sealant stuck to device components
1. Was the device storage temperature exceeded 25 °C?
EL
2. What location did the sealant stick to (e.g. catheter, advancer tube distal tip, balloon proximal tip)?
3. How much sealant was stuck to the device component?
4. Was the balloon fully deflated? TR
5. Was the sealant wedged between balloon and advancer tube?
Failure mode: Sealant Misdeployment / Sealant Exposed

NO
1. Was sealant dislodged?

2. Was the patient thin? Shallow vessel depth? (If weight and height were not provided in General
ED
Failure mode: Sealant Misdeployment (intravascular)/ Occlusion

1. Did the deployer fail to maintain tension on the catheter while tamping?
2. Was contrast/imaging used to confirm balloon placement?
OV

4. Was a procedural sheath that is greater than 7F used prior to introducing the Mynx?
5. Was the vessel < 5mm?
PR
6. What treatment was given to restore distal blood flow?

7. How many closure devices used in this patient?
AP
Procedure (Non-PPE)
Page 61 of 63
D
Product Clinical Complication:
Bleeding Events (Hematoma, Retroperitoneal Bleed)
SE
All Products:
EA
dosage.
3. What was the patient’s INR? >1.5?
EL
4. Did the vessel have stenosis >50% at or near the puncture site?
5. Was the target femoral site previously closed with any closure prior to this procedure?
6. Was there evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the
TR
access site prior to Mynx VCD use?
8. Was a procedural sheath that is greater than 7F used?
NO
9. Were there multiple stick attempts made before intravascular access was achieved?
10. Was hemostasis achieved?
11. Did the patient develop a hematoma immediately after the sealant was deployed? If not
a. Did hematoma develop during the patient’s recovery at hospital / at home?
ED
b. If yes: What was the patient’s activity when the bleeding started?
12. Was the puncture site located above the most inferior border of the inferior epigastric artery (IEA)
(High stick)?
OV
13. Was the puncture site below the bifurcation (Low stick)?
14. Was there a posterior wall puncture?
PR
Infection: (All Products)

1. Was the device packaging compromised during storage?
2. Was the packaging opened in a sterile field?
AP
3. Were hospital protocols (i.e. sterile technique) followed?

4. Did the patient receive prophylactic antibiotics prior to the procedure?
5. Was the patient under local or general anesthesia during the procedure?
6. Was the procedure performed as inpatient or outpatient?
a. If inpatient, how long was hospitalization?
7. How was the access site cleaned/maintained post-procedure?
Procedure (Non-PPE)
Page 62 of 63
8. Was the patient immunocompromised or has the patient experienced a recent infection (e.g. history
of MRSA, diabetes, cancer, pneumonia, etc.)?
If yes, please explain.
D
9. Was the patient a smoker?
10. Was the patient taking chemotherapy, steroid therapy or TNF inhibitors?
SE
Pulmonary Embolism/DVT
EA
1. Was manual pressure applied following closure? If yes, how long?
2. Were any compression devices or compression dressings used? If yes
a. What was used and for how long?
EL
3. How long was the patient on bed rest following the procedure?
4. Does the patient have any previous medical history of clots, blood-clotting disorders, heart failure,
obesity, cancer, or any other diseases that may have increased the patient’s risk of forming clots?
TR
5. Is the patient a smoker?
6. Was the patient taking any anticoagulants, antiplatelets or any thrombolytics? If yes, please provide
name and dosage.
NO
Death (All Products)

1. What was the patient’s date of death?
2. Was an autopsy performed?
ED
a. If yes, what were the results?

3. What was the official cause of death?
4. Does the patient have any significant medical history that may have contributed to the patient’s
OV
death?
5. Did the patient experience any adverse events prior to death?
a. If yes, please explain and provide any treatment that was given.
PR
Allergic Reaction / Sealant Expulsion

1. What symptoms did the patient experience?
AP
2. How were symptoms treated?

3. Does the patient have an allergy or sensitivity to Polyethylene glycols (macrogols)?
a. If yes, list the type of reaction caused by macrogols
4. Does the patient have any other known allergies or sensitivities?
a. If yes, provide a list of allergies and reactions.
Procedure (Non-PPE)
Page 63 of 63
D
CREGANNA – FAILURE TO CROSS QUESTIONS
SE
1) Was the product stored properly according to the instructions for use (IFU)?
2) Was there any damage noted to the product packaging upon inspection prior to use?
3) Was there any reported difficulty removing the product from the packaging?
EA
 Was there any difficulty removing the product from the hoop?
 Was there any difficulty removing the protective balloon cover?
 Was the shipping stylet and balloon cover removed before or after submerging in
heparinized saline solution?
EL
 Was there any difficulty removing the stylet or any of the sterile packaging
components?
4) Was the product inspected prior to use and appear to be normal?
TR
5) Were kinks or other damages noted prior to inserting the product into the patient?
6) Was the product prepped properly according to the IFU?
7) Did the device prep normally (i.e. maintain negative pressure)?
8) Is there any target lesion/target lesion characteristic information available?
NO
9) What was done to complete the procedure after the reported product issue?
10) Was the procedure completed successfully without patient injury?
11) Is the product being returned for inspection (and if yes, please provide the tracking
number)?
ED
12) Was there any other product issue noted either at the account after the procedure or
prior to shipping for inspection?
OV
PR
AP

Complaint Investigation Questionnaires

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Procedure 11774405 | Rev:12

performance of a device after it is released for

Coordinator communicating with complainant or reporter. Review

References External References:

1 Review all available Primary Data in the complaint file.

available Primary Data as compared to the appropriate

4. THROMBOTIC EVENTS – CARDIAC

5. MYOCARDIAL INFARCTION – CYPHER

7. DISSECTION / PERFORATION – CORONARY ARTERY

10. RESISTANCE-FRICTION / IMPEDED / TRACKING DIFFICULTY / OBSTRUCTED -

11. HUB LEAKAGE/CRACK – ANY PRODUCT THAT HAS A LUER HUB

12. BURST/LEAKAGE/INFLATION/DEFLATION/PREP/WITHDRAWAL DIFFICULTY –

14. FRACTURE / SEPARATIONS - STEERABLE GUIDEWIRES

15. PRECISE & SMART SELF EXPANDING STENTS (SES) –

PREPARATION / RESISTANCE-FRICTION-TRACKING / DEPLOYMENT DIFFICULTY / ADDITIONAL STENT

17. VENA CAVA FILTER -

18. LUMEND CATHETERS - OUTBACK & FRONTRUNNER

19. ANGIOGUARD EMBOLIC PROTECTION DEVICE

20. EXPIRATION DATE EXCEEDED COMPLAINTS

23. MYNX FAMILY

Cordis reference SR:

FACILITY / PRODUCT INFORMATION

INDEX PROCEDURE (REQUIRED DATA POINTS)

 Was the Index Procedure Emergent or Elective?

 Was the Lesion Pre-Dilated?

Cordis Product(s) Used

o Lesion type (A, B, C)

o If predilated, for how many seconds?

Cordis Product(s) Used

 Was the stent post-dilated?

 Was the reaction determined to be related to Non-Cordis Product?

 When was the damage noted?

o Outer Product Box (indicate below which part of the box)

 Bar Code Label

 Indicate the Labeling Deficiency (indicate all that apply)

o Were they overlapping?

 Was there good wall apposition of the stent?

THROMBOTIC EVENTS – CARDIAC

Cordis reference SR:

GENERAL PATIENT AND PROCEDURE QUESTIONS

 What were patient’s allergies pre procedure?

 Was the site predilated prior to stent implantation?

o What was the length and diameter of the predilation balloon

Were ACTS monitored in the case and what were they?

 What was the patient’s status at discharge?

 Date the patient returned with the restenosis?

Cordis reference SR:

GENERAL PATIENT AND PROCEDURE QUESTIONS

o Family history of CAD

o Post procedure allergies if different from above

CYPHER STENT PLACEMENT:

o If predilated, for how many seconds?

 What other meds were given during the procedure?

 Was the patient compliant with antiplatelet therapy?

 What was done to treat the restenosis?

DISSECTION/PERFORATION – CORONARY ARTERY

GENERAL PATIENT AND PROCEDURE QUESTIONS

Cordis Product(s) Used

 What caused the dissection/vessel perforation?

 Pre-procedural cardiac enzymes:

 Was IVUS done after the initial stent placement?

o If post dilated, at what inflation pressure (atmospheres)

 How was the fracture identified?