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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/11/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: customer phone = (b)(6).E3: customer occupation = unknown.Summary of event: it was reported that a bakri tamponade balloon catheter leaked after placement.Following a cesarean section delivery, a patient required a bakri balloon for intrauterine tamponade after losing ~550ml of blood.The balloon was placed through the vagina and a total of 250 ml was injected into the balloon.A large amount of liquid was expelled from the uterine incision.The balloon was removed and the leaking was noted.The procedure was completed by using another new device.The patient lost an additional ~60ml following the device issue.The patients total estimated blood loss was ~700ml.The patient was considered to be hemodynamically stable and there was no need for a transfusion of blood products.The user denies the proximity of any metal tools around the balloon that might have caused damage to the balloon.Additionally, there was no damage noted to the packaging material of the device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.A document-based investigation evaluation was performed.A search of the device history record found no related non-conformances reported for lot 14298150.A complaint history database search showed no other related complaints associated with the complaint device lot 14298150.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The ifu [t_j-sosr_rev4; 'bakri postpartum balloon'] supplied with the device states the following in consideration of the reported failure mode: - 'how supplied: upon removal from the package, inspect the product to ensure no damage has occurred.' the complaint device was not returned; therefore, no functional testing or visual inspections could be performed.The complaint was confirmed based on customer testimony.Based upon the available information and results of the investigation, cook has concluded that the cause for the complaint could not be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, 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

It was reported that a bakri tamponade balloon catheter leaked after placement.Following a cesarean section delivery, a patient required a bakri balloon for intrauterine tamponade after losing ~550ml of blood.The balloon was placed through the vagina and a total of 250 ml was injected into the balloon.A large amount of liquid was expelled from the uterine incision.The balloon was removed and the leaking was noted.The procedure was completed by using another new device.The patient lost an additional ~60ml following the device issue.The patients total estimated blood loss was ~700ml.The patient was considered to be hemodynamically stable and there was no need for a transfusion of blood products.The user denies the proximity of any metal tools around the balloon that might have caused damage to the balloon.Additionally, there was no damage noted to the packaging material of the device.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

• 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: 17686004
• MDR Text Key: 322716292
• Report Number: 1820334-2023-01190
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)241021(10)14298150
• 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,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 14298150
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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 Age: 30 YR
• Patient Sex: Female
• Patient Weight: 61 KG