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

Catalog Number J-SOS-100500

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

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

Event Date 11/03/2023

Event Type  malfunction  

Manufacturer Narrative

E3: customer occupation = unknown.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' was used following a vaginal delivery.The user placed the device vaginally and inflated the balloon with 200ml; it was then noted that there was a pinhole leak in the balloon material.The device was removed and replaced with a new 'bakri tamponade balloon catheter'.The patient lost approximately 380ml of blood prior to device use and additional 20ml following the device use; total estimated blood loss was 400ml.The patient did not require any blood transfusions.The device was not handled by or in the proximity of any metal tools.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation: evaluation: as reported, a 'bakri tamponade balloon catheter' was used following a vaginal delivery.The user placed the device vaginally and inflated the balloon with 200ml; it was then noted that there was a pinhole leak in the balloon material.The device was removed and replaced with a new 'bakri tamponade balloon catheter'.The patient lost approximately 380ml of blood prior to device use and additional 20ml following the device use; total estimated blood loss was 400ml.The patient did not require any blood transfusions.The device was not handled by or in the proximity of any metal tools.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures were conducted during the investigation.Functional tests and visual inspection of the returned complaint device were also conducted.One, used, 'bakri tamponade balloon catheter' was returned for investigation.A pinhole leak was observed in the balloon material.There were no visible tool marks in the material under magnification.Additionally, the stopcock was loose and, once tightened, did not leak during a function test.However, the stopcock did loosen during the function test.Cook has concluded that the device was manufactured to specification.Additionally, 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 device history record (dhr) found no related non-conformances reported for lot.A complaint history database search showed two other related complaints associated with the failure mode for the complaint device for lot.Due to the individual nature of the manufacturing and inspection process for the devices in the lots, it is unlikely that these events are an indication of device issue within the entire lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling; the ifu [t_j-sos_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." based upon the available information and results of the investigation, cook has concluded that a definitive cause of the leakage event and the stopcock separation event could not be determined from the available information.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

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: 18381175
• MDR Text Key: 331485115
• Report Number: 1820334-2023-01753
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)240818(10)14159274
• 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,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 14159274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2021
• 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 Sex: Female