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

Catalog Number J-SOS-100500

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Event summary as reported, during an unspecified procedure, a bakri tamponade balloon catheter's balloon had a leak and would not inflate.The procedure was complete with another same-like device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.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.The complaint device was not returned; therefore, no physical examinations could be performed.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 complaints associated with the reported device lot.Review of the device history record, complaint history, and quality control documents does not indicate that the device was manufactured out of specification and does not suggest items in the lot or similar devices in the field or in house are nonconforming.Cook also reviewed product labeling.The product ifu, t_j-sos_rev4 ¿bakri postpartum balloon,¿ provides the following information to the user related to the reported failure mode: warnings "the balloon should be inflated with sterile liquid such as sterile water, sterile saline, or lactated ringers solution.The balloon should never be inflated with air, carbon dioxide or any other gas." balloon inflation "warning: always inflate the balloon with sterile liquid.Never inflate with air, carbon dioxide or any other gas." how supplied "upon removal from the package, inspect the product to ensure no damage has occurred." based on the available information, no product returned, and the results of the investigation, a definitive cause of the event could not be determined.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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

As reported, during an unspecified procedure, a bakri tamponade balloon catheter's balloon had a leak and would not inflate.The procedure was complete with another same-like device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Correction: h10 - event summary, ifu.Event summary as reported, the complaint device was placed following delivery.When the doctor attempted to inflate the balloon with under 20ml of saline, there was leakage from the balloon.The estimated blood loss prior to the device failure was 300 - 500ml, and the total estimated blood loss was 500 - 800ml.Another bakri balloon was used to complete the procedure.No blood transfusions were administered, and no other adverse effects were reported.Cook also reviewed product labeling.The product ifu, t_j-sos_rev4 ¿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.' 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

Additional information received: the balloon was inflated with under 20ml of saline.The leak was found coming from the balloon.The total estimated blood loss was 500~800ml.The estimated blood loss before the device failure was 300~500ml.Immediately after the device leaked, they used another same-like device.

• 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: 19011864
• MDR Text Key: 339051438
• Report Number: 1820334-2024-00450
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)261027(10)NS15731084
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• 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: NS15731084
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2023
• 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