MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; OQY INTRAUTERINE BALLOON

Model Number G30673

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2023

Event Type  Injury  

Manufacturer Narrative

E1: phone: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

As reported, a 'bakri tamponade balloon catheter' deflated during use while the patient was being treated for postpartum hemorrhage.Prior to device placement, the user attempted to treat the hemorrhage with an increased dose of medication to stimulate uterine contractions and gauze compression of the cervix.Approximately 20 minutes after delivery, the user placed the device with placental forceps and packed with iodoform gauze.The user then inflated the balloon with 150ml sterile water; approximately 30 minutes later, the user injected an additional 50ml of sterile water for a total of 200ml.Approximately, 15 hours after device placement, the user performed an ultrasound to check hemostasis and was unable to locate the balloon.The user then attempted to locate the balloon and found it was deflated and had slipped into the vaginal canal.The user then repositioned the device and inflated the balloon with an unknown amount of sterile water.After approximately 5 hours, hemostasis was achieved and the device was removed.At time of removal, the device was not deflated, however, blood was noted in the balloon and the sterile water was stained red.The patient had a total estimated blood loss of 1660ml prior to device placement; it was reported that the patient did not have any additional blood loss following device placement.The patient was transfused with 4 units of red blood cells and 4 units of fresh frozen plasma due to the anemia.The patient remained 'fairly stable' kinetically.

Manufacturer Narrative

H3: device evaluated by mfg: other (81): device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information received on 31jul2023 and 04aug2023.The bakri tamponade balloon catheter was placed at 19:00.At 19:30, a blood transfusion was performed due to anemia.The next day, at 10:00, the balloon had deflated to its original size and slipped into the vaginal canal.200 milliliters of sterile water was injected into the balloon and retained.While the balloon was indwelling, it was monitored by "japanese guidelines", which includes blood pressure, heart rate, and sp02 (pulse oximeter) monitoring.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, 20 minutes after delivery the cook bakri tamponade balloon catheter was placed with placental forceps at 19:00, inflated to 150ml with sterile water, and packed with iodoform gauze.At 19:30, 50ml was added to the balloon.Blood transfusion of 4 units of red blood cells (480 ml) and 4 units of fresh frozen plasma (480 ml) were performed due to anemia.The bleeding seemed to have almost stopped at the time of transfusion.At about 10:00, an ultrasound was used to check the hemostasis, and the balloon could not be found.The operator attempted to remove the balloon and found that it had deflated and slipped into the vaginal canal.Sterilized water was added again, and the balloon was left in place for 5 hours.While the balloon was indwelling, it was monitored by "japanese guidelines", which includes blood pressure, heart rate, and sp02 (pulse oximeter) monitoring.After confirming that there was no bleeding, the balloon was removed.The bakri balloon was not deflated, but blood had entered the balloon and the sterile water was stained red.The total estimated blood loss before the balloon deflated was 1,660 ml, and the total estimated blood loss after atrophy remained the same.Interventions performed prior to attempting balloon placement were increased dose of uterine contractions and gauze compression of the cervix.The patient was fairly stable kinetically.Hemostasis was determined to have been successful.No other adverse effects were reported.Investigation ¿ evaluation.A document-based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection and functional test of the device were conducted.The complaint device was returned to cook for evaluation.The balloon was function tested, and a leak was observed at the proximal tip.Slight tugging on the balloon material pulled the proximal end loose from the catheter.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Review of the device history record, complaint history, relevant manufacturing documents, and device failure analysis indicated that the device was manufactured to specification.Cook also reviewed product labeling.The product ifu, ¿bakri postpartum balloon,¿ provides the following information to the user related to the reported failure mode: how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded a definitive cause of the reported event could not be determined from the available information.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17371833
• MDR Text Key: 319555378
• Report Number: 1820334-2023-00948
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)250920(10)14965226
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 14965226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female