Every Second Matters – Uterine Balloon Tamponade (ESM-UBT)

INTENDED USE
This device is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.

Caution: Federal law restricts use of this device to licensed healthcare practitioners.

COMPONENTS IN ESM-UBT KIT

1. Urinary catheter
2. Luer lock valve
3. Condom
4. Syringe
5. Elastic O-ring
6. Catheter holder
7. Antiseptic (povidone iodine) prep pad

CONTRAINDICATIONS
• Pregnancy
• Known advanced cervical cancer
• Known uterine rupture
• Purulent infections in the vagina, cervix, or uterus
• A surgical site that would prohibit the device from effectively controlling bleeding

WARNINGS
• ESM-UBT is a single use device. Do not use it multiple times.
• Use of this device should not delay appropriate application of other critical interventions such as uterotonics, blood products, angiography
and/or surgery.
• The ESM-UBT device is indicated for use in the event of primary postpartum hemorrhage within 24 hours of delivery.
• The device should not be left indwelling for more than 24 hours.
• The balloon of the urinary catheter and the condom balloon should be inflated with sterile saline. The balloon should never be inflated with
air, carbon dioxide, or any other gas.
• The inflation of the balloon of the urinary catheter is 15 mL. Do not overinflate it.
• The recommendation for maximum inflation of the condom balloon is 500 mL. Do not overinflate the condom balloon.
• Patients in whom the device is being used should be closely monitored for signs of worsening bleeding and/or disseminated intravascular coagulation (DIC).
In such cases, emergency intervention per hospital protocol should be followed.
• Patient monitoring is an integral part of managing postpartum hemorrhage. Signs of deteriorating or non-improving condition should lead to a more
aggressive treatment and management of patient uterine bleeding.
• Patient urine output should be monitored while the ESM-UBT device is in use.

PRECAUTIONS
• Avoid excessive force when inserting the balloon into the uterus.

INSTRUCTIONS FOR USE

• Device Assembly
WARNING: The device should be assembled in an ISO certified clean room.
WARNING: We recommend assembling the device in a sterile field to minimize the chance of infection related to contamination

1. Locate the one-way Luer lock valve in the draining port of the urinary catheter.
2. Take the condom balloon out of the packaging and roll it out completely.
3. Insert the Foley catheter into the condom. The balloon on the Foley catheter should be inside the condom balloon.
4. Secure the condom at the end of the Foley urinary catheter by four twist-ties of the O-ring around the condom-catheter interface below the small Foley
catheter balloon.
5. Take the antiseptic prep pad (10% povidone iodine) out of the packaging and gently wipe the entire surface of the condom and O-ring
6. Attach the 60 mL syringe to the Luer lock.

• Transvaginal Placement
1. Insert the assembled balloon-catheter into the bleeding uterus through the cervical opening.
2. Make certain that the entire balloon is inserted past the cervical canal and internal ostium.

• Balloon Inflation (With Syringe)

WARNING: Never inflate with air, carbon dioxide or any other gas.
WARNING: The maximum recommended inflation of condom balloon is 500 mL. Do not overinflate the balloon.
WARNING: The small port (Catheter balloon port) on the Foley catheter is used for the syringe to inject saline into the balloon of the urinary catheter,
whereas the larger port (Condom balloon port) is used to inflate the condom balloon. Use the correct port in each step.

1. Instill 15 mL of saline through the small port (Catheter balloon port) to inflate the balloon of the Foley catheter and help secure the device inside the
uterus.
2. Instill saline through the larger port (Condom balloon port) with the Luer lock valve to inflate the condom balloon.
3. Fill the condom balloon with saline until the bleeding stops. This usually requires 300-500 mL but may vary considerably. The maximum recommended
inflation for ESM-UBT is 500 mL
4. Fix the shaft of the ESM-UBT device to the patient’s thigh with the catheter holder.

IMPORTANT: To ensure that the balloon is filled to the desired volume, it is recommended that the predetermined volume of fluid be placed in a separate
container, rather than relying on a syringe count to verify the amount of fluid that has been instilled into the balloon.
NOTE: See the instruction card in the kit for proper assembly and placement
NOTE: If considerable resistance is felt while inflating the balloon and bleeding persists, pause fluid instillation and re-examine balloon placement to ensure
that it is correctly inside the uterus and there are no other sources of bleeding.
NOTE: Once the balloon is inflated, place an indwelling urinary bladder Foley catheter, if not already in place, to collect and monitor urine output.

1
 • Monitoring
1. When the bleeding stops, the patient is ready for careful observation or transfer to a referral facility. The ESM-UBT device should stay in place for at
least 6-24 hours and should always be kept in place during transfer.
2. Monitor the patient continuously for signs of increased bleeding and uterine cramping.
5. A single prophylactic dose of antibiotics is recommended when the uterine balloon is placed.
6. The patient should be given appropriate IV fluids or blood replacement products until she is stable and no longer heavily bleeding.

• Balloon Removal
NOTE: The timing of balloon removal should be determined by the attending clinician upon evaluation of the patient once bleeding has
been controlled and the patient stabilized.
1. Using the 60 ml syringe remove 50-100 ml of fluid from the condom balloon to decrease pressure. Observe for 30 – 60 minutes for return of bleeding.
Re-inflate if bleeding resumes. If bleeding remains arrested, fully deflate the saline from the condom balloon using the larger port (Condom balloon port).
2. Remove 15 mL saline from the small port (Catheter balloon port) to deflate the balloon of the urinary catheter.
3. Detach the ESM-UBT device from the catheter holder.
4. Remove the device from the patient’s uterus and vagina.

NOTE: Once the device is removed, check the device components and make sure the components are not detached and left inside the uterus. The Foley
catheter, the condom balloon and the O-ring all need to be removed from the patient’s body. Refer patients to a higher lever care facility if a component remains in
the uterus”

HOW SUPPLIED
Supplied non-sterile. An antiseptic prep pad (10% povidone iodine solution) is included in the kit for disinfecting the assembled device prior to transvaginal
placement. Intended for one-time use. Store in a location where the ESM-UBT may be available immediately upon emergency. Upon removal from the package,
inspect the product to ensure no damage has occurred.

SHELF-LIFE
The shelf-life of the device is three years

LITERATURE
Ujenzi provided peer-reviewed publications (listed below) to support use of the ESM-UBT device in the intended use population. Over 900 devices have been used in
India, Tanzania, Kenya, Senegal, Sierra Leone, and Nepal. The results of the publications demonstrate the subject device is effective in managing PPH, led to high
survival rates and low rates of complications. Ujenzi assessed the severity, expectedness, and relatedness of each reported death and provided this information to an
independent committee for review. There have been no deaths or disabilities related to the ESM-UBT device. Interviews with healthcare workers also demonstrate
that the device can be placed without difficulty, complication, or discomfort.

The sponsor provided the following publications:

1. Burke TF, et al. “A Postpartum Hemorrhage Package with Condom Uterine Balloon Tamponade: A Prospective Multi-Centre Case Series in Kenya, Sierra Leone,
Senegal, and Nepal.” Royal College of Obstetricians and Gynecologists 2015.
2. Burke TF, et al. “Shock Progression and Survival After Use of a Condom Uterine Balloon Tamponade Package in Women with Uncontrolled Postpartum
Hemorrhage.” International Journal of Gynecology and Obstetrics 2017.
3. Burke TF, et al. “Time for Global Scale-Up, not Randomized Trials, of Uterine Balloon Tamponade for Postpartum Hemorrhage.” Int J Gynecol Obstet 2018.
4. Makin J, et al. “Innovative Uses of Condom Uterine Balloon Tamponade for Postpartum Hemorrhage in India and Tanzania.” Case Reports in Obstetrics and
Gynecology 2018.
5. Ramanathan A, et al. “Safety of a Condom Uterine Balloon Tamponade (ESM-UBT) Device for Use in Uncontrolled Postpartum Hemorrhage among Facilities in
Kenya and Sierra Leone.” BMC Pregnancy and Child Birth 2018.
6. Tindell K, et al. “Uterine Balloon Tamponade for the Treatment of Postpartum Haemorrhage in Resource-Poor Settings: A Systematic Review.” BJOG 2012.
7. A Low-Cost Uterine Balloon Tamponade Program for Uncontrolled PPH in India: A Two Group Interrupted Time Series Evaluation” Harvard Medical School,
Harvard T.H. Chan School of Public Health and Massachusetts General Hospital White Paper.
8. Altawil Z, et al. “Uterine Balloon Tamponade for the Management of Uncontrolled Postpartum Hemorrhage by Midwives and Family Physicians.” International
Journal of Nursing and Midwifery 2017.
9. Fehling M, et al. “Development of a Community-Based Maternal, Newborn and Child Emergency Training Package in South Sudan.” Public Health 2013.
10. Natarajan A, et al. “Provider Experiences with Improvised Uterine Balloon Tamponade for the Management of Postpartum Hemorrhage in Kenya.” International
Journal of Gynecology and Obstetrics 2016.
11. Natarajan A, et al. “Provider Experiences with Uterine Balloon Tamponade for Uncontrolled Postpartum Hemorrhage in Health Facilities in Kenya.” International
Journal of Gynecology and Obstetrics 2015.
12. Natarajan A, et al. “Provider Experience of Uterine Balloon Tamponade for the Management of Postpartum Hemorrhage in Sierra Leone.” International Journal
of Gynecology and Obstetrics 2016.
13. Nelson BD, et al. “Evaluation of a Novel Training Package Among Frontline Maternal, Newborn, and Child Health Workers in South Sudan.” International Journal
of Gynecology and Obstetrics 2012.
14. Nelson BD, et al. “Use of Uterine Balloon Tamponade for Control of Postpartum Hemorrhage by Community-Based Health Providers in South Sudan.”
International Journal of Gynecology and Obstetrics 2013.
15. Pendleton AA, et al. “A Qualitative Assessment of the Impact of a Uterine Balloon Tamponade Package on Decisions Regarding the Role of Emergency
Hysterectomy in Women with Uncontrolled Postpartum Hemorrhage in Kenya and Senegal.” BMJ Open 2016.
16. Herrick T, et al. “A Low-Cost Uterine Balloon Tamponade for Management of Postpartum Hemorrhage: Modeling the Potential Impact on Maternal Mortality
and Morbidity in Sub-Saharan Africa.” BMC Pregnancy and Childbirth 2017.
17. Mvundura M, et al. “Cost-Effectiveness of Condom Uterine Balloon Tamponade to Control Severe Postpartum Hemorrhage in Kenya.” International Journal of
Gynecology and Obstetrics 2017.
18. Nelson BD, et al. “Innovative Package for Frontline Maternal, Newborn and Child Health Workers in South Sudan.” South Sudan Medical Journal 2011.
19. Pendleton AA, et al. “Emergency Hysterectomy for Uncontrolled Postpartum Hemorrhage may be Averted Through Uterine Balloon Tamponade in Kenya and
Senegal.” International Federation of Gynecology and Obstetrics 2015.

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