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 Swelling/ Edema (4577)

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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 or that a death or serious injury occurred; nor is it admission 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 a treatment for postpartum hemorrhage following a cesarean section, a bakri tamponade balloon catheter's balloon leaked.After the cesarean section, the bakri balloon was placed, and the patient returned to the ward.The patient had abdominal swelling and returned to the operating room.A pinhole leak was noted in the balloon, and it was replaced by a new product.Approximately 430ml of blood loss occurred before the device leaked and an additional 50ml after.The patient was hemodynamically stable.No transfusions were administered.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 other additional intervention or experience any adverse effects due to this occurrence.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation evaluation as reported, during a treatment for postpartum hemorrhage following a cesarean section, a 'bakri tamponade balloon catheters' balloon leaked.After the cesarean section, the bakri balloon was placed, and the patient returned to the ward.The patient had abdominal swelling and returned to the operating room.A pinhole leak was noted in the balloon, and it was replaced by a new product.Approximately 430ml of blood loss occurred before the device leaked and an additional 50ml after.The patient was hemodynamically stable.No transfusions were administered.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 other additional intervention or 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(s) was/were also conducted.One, used, 'bakri tamponade balloon catheter' was returned for investigation.Tool marks and a small puncture in the balloon material was observed.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 no other related complaints associated with the failure mode for the complaint device for lot.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 was confirmed based on customer testimony and evaluation of the returned device.The returned device appeared to be damaged by another device of unknown origin.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.

• 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: 18615957
• MDR Text Key: 334493394
• Report Number: 1820334-2024-00143
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)241021(10)14298152
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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: 14298152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 32 YR
• Patient Sex: Female
• Patient Weight: 65 KG