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	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1-(customer person) title: unknown, postal code: (b)(6).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
It was reported that, the balloon of the bakri tamponade balloon catheter leaked during the treatment of postpartum hemorrhage (pph) in a female patient of unknown age.The patient had a normal delivery with postpartum hemorrhage due to weak contractions (uterine atony).A bakri balloon was inserted into the uterus through the vagina with a toothless oval forceps, but after five minutes, it was found that there was a leakage from the balloon.The water was injected again but the balloon still leaked.The damaged balloon was removed, and a new balloon was reinserted to gradually stop the bleeding.The balloon was inflated to 450 milliliters.The total estimated blood loss was 550 milliliters, out of which, 350 milliliters was lost before the device failure and 250 milliliters was lost after the device failure.The patient did not require any blood transfusions.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
Corrected information: the balloon was inflated to 450 milliliters.The total estimated blood loss was 550 milliliters, out of which, 350 milliliters was lost before the device failure and 200 milliliters was lost after the device failure.The patient did not require any blood transfusions.
Additional Manufacturer Narrative
Correction: b5.Investigation ¿ evaluation: it was reported that, the balloon of the bakri tamponade balloon catheter leaked during the treatment of postpartum hemorrhage (pph) in a female patient of unknown age.The patient had a normal delivery with postpartum hemorrhage due to weak contractions (uterine atony).A bakri balloon was inserted into the uterus through the vagina with a toothless oval forceps, but after five minutes, it was found that there was a leakage from the balloon.The water was injected again but the balloon still leaked.The damaged balloon was removed, and a new balloon was reinserted to gradually stop the bleeding.The balloon was inflated to 450 milliliters.The total estimated blood loss was 550 milliliters, out of which, 350 milliliters was lost before the device failure and 200 milliliters was lost after the device failure.The patient did not require any blood transfusions.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the documentation, including the complaint history, device history record, quality control procedures, and instructions for use (ifu) for the device, as well as visual inspection and functional test of the returned product were conducted during the investigation.The complaint device was returned without package or label.Upon inspection no damage to the device was noticed.The balloon was inflated with water and a lumen communication was observed.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) for the device found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling: the product ifu, ¿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." evidence gathered upon review of the dhr, complaint history, quality control documents, and device failure analysis 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.Based on the information provided, examination of the returned product, and the results of our investigation, a definitive cause for the failure could not be established.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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: 21071905
• Report Number: 1820334-2025-00013
• Device Sequence Number: 20926017
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)270311(10)15939678X
• Combination Product (Y/N): N
• 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): 01/20/2025

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: 15939678X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2024
• 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 Sex: Female