1. SOS BAKRI TAMPONADE BALLOON CATHETER
Illustration by Lisa Clark
The Simple Solution for Postpartum Hemorrhage

2. Contents Discussion Introduction Indications
Steps for Balloon Application
Comparison to Existing Manual Treatments
References
Support Info
SOS Bakri Tamponade Balloon Catheter

3. Discussion
Postpartum hemorrhage (PPH) is defined as bleeding that occurs immediately after the placenta is delivered.
PPH remains in the top five causes of maternal death in both developed and developing countries.
SOS Bakri Tamponade Balloon Catheter

4. Discussion
PPH is an emergent situation. The decision for appropriate treatment must be made in a matter of minutes.
Patients with PPH can deteriorate very quickly.
SOS Bakri Tamponade Balloon Catheter

5. Discussion
Estimates of the incidence of PPH range from as few as 1:100 to as frequent as 1:20.
The indications for use of the SOS Bakri Balloon Catheter are for temporary management of lower uterine segment bleeding. Indicated in about one third of all PPH cases.
SOS Bakri Tamponade Balloon Catheter

6. Introduction
Various management measures are utilized for control of bleeding.
Uterotonics
Packing
Manual Compression
Embolization
Hysterectomy
SOS Bakri Tamponade Balloon Catheter

7. Introduction
The ideal choice for managing a patient’s postpartum hemorrhage:
Easily administered and removed.
Control of capillary/venous bleeding and surface oozing.
Ability to gauge success of treatment in real time.
Avoid hysterectomy to preserve the patient’s reproductive potential.
SOS Bakri Tamponade Balloon Catheter

8. Introduction The SOS Bakri Tamponade Balloon by Cook Ob/Gyn:
Easily administered
Quickly ascertain effectiveness.
Able to gauge ongoing blood-loss through inner lumen.
Removes easily without need for separate surgical procedure.
Conservatively manages hemorrhage.
SOS Bakri Tamponade Balloon Catheter

9. Indications
The SOS Bakri Balloon catheter is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
SOS Bakri Tamponade Balloon Catheter

10. Indications
While the device is intended as a temporary means of establishing hemostasis in cases indicating conservative management of postpartum uterine bleeding, the application of this device should be concomitant with close monitoring for signs of arterial bleeding, atony bleeding, and/or disseminated intravascular coagulation (DIC).
SOS Bakri Tamponade Balloon Catheter

11. The use of this product is contraindicated in the presence of:
Contraindications
The use of this product is contraindicated in the presence of:
Arterial bleeding requiring surgical exploration or angiographic embolization.
Uterine atony bleeding.
Cases indicating hysterectomy.
Pregnancy
SOS Bakri Tamponade Balloon Catheter

12. Contraindications (cont.)
The use of this product is contraindicated in the presence of:
Cervical cancer
Purulent infections of the vagina, cervix, or uterus.
Untreated uterine anomaly.
SOS Bakri Tamponade Balloon Catheter

13. Contraindications (cont.)
The use of this product is contraindicated in the presence of:
Disseminated intravascular coagulation.
A surgical site which would prohibit the device from effectively controlling bleeding.
SOS Bakri Tamponade Balloon Catheter

14. Application Vaginal Delivery -- Transvaginal Placement:
Determine uterus is clear of any retained placental fragments, arterial bleeding, or lacerations.
Determine approximate uterine volume by ultrasound or direct examination.
Insert the balloon portion of the catheter in the uterus, making certain that the entire balloon is inserted past the cervical canal and internal ostium, under ultrasound guidance.
SOS Bakri Tamponade Balloon Catheter

15. Application Vaginal Delivery -- Transvaginal Placement (cont.):
Note: Avoid excessive force when inserting the balloon into the uterus.
If not already indwelling, place a Foley catheter in patient bladder to collect and monitor urine output.
To ensure maintenance of correct placement and maximize tamponade effect, the vaginal canal may be packed with iodine or antibiotic soaked vaginal gauze at this time.
SOS Bakri Tamponade Balloon Catheter

16. Application Cesarean Delivery -- Transabdominal Placement:
Determine uterus is clear of any retained placental fragments, arterial bleeding, or lacerations.
Determine uterine volume by intraoperative direct examination or postoperative ultrasound examination.
SOS Bakri Tamponade Balloon Catheter

17. Application Cesarean Delivery -- Transabdominal Placement (cont.):
From above (via access of the Cesarean incision), pass the tamponade balloon, inflation port first, through the uterus and cervix.
Have an assistant pull the shaft of the balloon through the vaginal canal, until the deflated balloon base comes in contact with the internal cervical ostium.
SOS Bakri Tamponade Balloon Catheter

18. Application Cesarean Delivery -- Transabdominal Placement (cont.):
Close the incision per normal procedure, taking care to avoid puncturing the balloon while suturing.
If not already indwelling, place a Foley catheter in patient bladder to collect and monitor urine output.
SOS Bakri Tamponade Balloon Catheter

19. Application Cesarean Delivery -- Transabdominal Placement (cont.):
To ensure maintenance of correct placement and maximize tamponade effect, the vaginal canal may be packed with iodine or antibiotic soaked vaginal gauze at this time.
SOS Bakri Tamponade Balloon Catheter

20. Application Instructions for Balloon Inflation
Note: Always inflate the balloon with sterile liquid. Never inflate with air, carbon dioxide, or any other gas.
Note: Do not over-inflate the balloon. Please refer to product label for maximum inflation volume.
Ensure that indwelling Foley is placed in patient bladder at this time.
SOS Bakri Tamponade Balloon Catheter

21. Application Instructions for Balloon Inflation (cont.)
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 solely relying on a syringe count to verify the amount of fluid that has been instilled into the balloon.
Using the enclosed syringe, begin filling the balloon to the predetermined volume through the stopcock.
SOS Bakri Tamponade Balloon Catheter

22. Application Instructions for Balloon Inflation (cont.)
Apply gentle traction to the balloon shaft to ensure proper contact between the balloon and tissue surface. To maintain tension, secure the balloon shaft to the patient’s leg or attach to a weight, not to exceed 500 grams.
Note: If balloon becomes dislodged due to shaft tension and cervical dilation, deflate, reposition, and re-inflate. Use of vaginal packing may be indicated at that time to aid in balloon placement.
SOS Bakri Tamponade Balloon Catheter

23. Application Patient Monitoring
Once balloon is placed and is inflated, connect the drainage port to a fluid collection bag to monitor hemostasis.
IMPORTANT: To adequately monitor hemostasis, the balloon drainage port and tubing should be flushed clear of clots with sterile isotonic saline.
Patient should be monitored continuously for signs of increased bleeding, uterine cramping, or a deteriorating condition.
Patient monitoring should include, but not be limited to: Blood pressure, pulse, urine output, cramping, pallor, and active bleeding.
SOS Bakri Tamponade Balloon Catheter

24. Application Patient Monitoring (cont.)
IMPORTANT: Signs of deteriorating or non-improving conditions should indicate more aggressive treatment and management of patient uterine bleeding.
IMPORTANT: This device is not a substitute for surgical management and fluid resuscitation of life-threatening postpartum hemorrhage.
SOS Bakri Tamponade Balloon Catheter

25. Application Balloon Removal
Maximum indwell time is twenty-four (24) hours. Balloon may be removed sooner upon physician determination of hemostasis or need to apply more aggressive treatment.
Remove tension from balloon shaft.
Remove any vaginal packing.
Using an appropriate syringe, aspirate the contents of the balloon until fully deflated.
Gently retract the balloon from the uterus and vaginal canal and discard.
Continue to monitor the patient for signs of uterine bleeding.
SOS Bakri Tamponade Balloon Catheter

26. Comparison Uterine Packing Bakri Balloon Nominal Material Cost
Possible concealed hemorrhage
No record of blood loss
Potential uterine trauma during application.
Removal post-treatment can require an additional trip to OR.
Bakri Balloon
Bakri balloon comes packaged with syringe, and stores like other surgical tools.
May be applied quickly and easily.
Open inner lumen allows for direct measurement of ongoing blood loss.
Silastic balloon conforms to uterine cavity decreasing chance of uterine trauma.
Can be removed quickly without additional invasive procedure.
SOS Bakri Tamponade Balloon Catheter

27. Comparison Sengstaken-Blakemore Balloon Foley Catheters
This is a naso-gastric balloon for tamponade of esophageal varicoceles and the introduction of contrast media.
Does not necessarily take uterine shape.
Expensive
Contains latex
Not indicated for management of PPH.
Foley Catheters
Inexpensive, but are generally ineffective in a large, postpartum uterine cavity.
The application of multiple Foleys is cumbersome and less effective than the Bakri Balloon.
If applied individually without an overbag, Foleys do not readily conform to uterine anatomy.
Foley’s applied jointly in a plastic covering or overbag, do not allow for proper drainage, and can conceal uterine hemorrhage.
Contains latex
Not indicated for management of PPH.
SOS Bakri Tamponade Balloon Catheter

28. SOS Bakri Tamponade Balloon Catheter

29. SOS Bakri Tamponade Balloon Catheter
100% Silicon (no latex)
Ductile shape allows it to conform to uterine anatomy and shape.
It allows for hemostatic cushion application, and limits clot adhesion.
The large diameter lumen in the shaft and multi-ported, non-abrasive tip allows for constant drainage, so an ongoing uterine hemorrhage does not go undetected post-application
Once deflated the Bakri Balloon is easily removed trans-vaginally without the need for an additional surgical procedure.
Approved by the FDA for specific application to postpartum hemorrhage.
SOS Bakri Tamponade Balloon Catheter

30. Primary References
Bakri YN, et al. Tamponade-balloon for obstetrical bleeding. Int. J. Gynecol. Obstet. 2001; 74:
G. S. Condous, et al. The “Tamponade Test” in the Management of Massive Postpartum Hemorrhage. Obstetrics and Gynecology (2003) vol. 101, no. 4:
SOS Bakri Tamponade Balloon Catheter

31. Support FDA 510K Cleared: #K013597
Tamponade Uterine Balloon Catheter Set
Regulation number: 21 CFR
Regulation Name: Obstetric-gynecologic specialized manual instrument
Class: II
Product Code: 85 KNA
Approval Date: March 6, 2002
Order Number: J-SOS
SOS Bakri Tamponade Balloon Catheter

32. Contact COOK® Medical Incorporated 750 Daniels Way, P.O. Box 4195
Bloomington, IN U.S.A.
Phone:
Toll Free:
Toll Free Fax:
SOS Bakri Tamponade Balloon Catheter