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

Model Number	G30673
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A5: ethnicity: han chinese.E1: phone number: (b)(6).H3: device evaluation anticipated but not yet begun.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 or Problem Description
As reported, during treatment of postpartum hemorrhage, secondary to uterine atony, the 'bakri tamponade balloon catheter' leaked.The issue was identified when saline was injected to check the integrity of the well packed balloon catheter before transvaginal placement.Reportedly, blood loss prior to failure is unknown since the balloon was not used on the patient.The procedure was successfully completed by replacing with an unspecified new balloon.Reportedly, the postoperative total bleeding was 400 ml with no transfusion performed, and the final hemostasis was successful.A section of the device did not remain inside the patient's body.The patient did not require any additional procedure or experience adverse effects due to this event.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation.As reported, during treatment of postpartum hemorrhage, secondary to uterine atony, the 'bakri tamponade balloon catheter' leaked.The issue was identified when saline was injected to check the integrity of the well packed balloon catheter before transvaginal placement.Reportedly, blood loss prior to failure is unknown since the balloon was not used on the patient.The procedure was successfully completed by replacing with an unspecified new balloon.Reportedly, the postoperative total bleeding was 400ml with no transfusion performed, and the final hemostasis was successful.A section of the device did not remain inside the patient's body.The patient did not require any additional procedure or experience adverse effects due to this event.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturer¿s instructions (mi), and quality control (qc) procedures were conducted during the investigation.Functional tests and visual inspection of the returned complaint device was also conducted.One device was returned for investigation in shipping tray.A functional leak test was performed, and the balloon leaked from a pin hole in the balloon material.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 the failure mode.A complaint history database search revealed 2 other complaints associated with the complaint device 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.Cook also reviewed product labeling; the ifu 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, inspection of the returned device, and results of the investigation, cook has concluded that the cause for the complaint could not be established.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.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Common Device Name: 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: 22833967
• Report Number: 1820334-2025-01015
• Device Sequence Number: 13153391
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)270715(30)1(10)16152847
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K170622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 16152847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Race: Asian