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

Model Number N/A

Device Problem Material Rupture (1546)

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

Event Date 10/31/2023

Event Type  malfunction  

Event Description

It was reported that a the balloon of a 'bakri tamponade balloon catheter' ruptured after placement.The 'bakri' device was required for a patient post-cesarean delivery for a postpartum hemorrhage of an estimated 850 ml blood loss.After suturing the cesarean section incision closed, the balloon was placed transvaginally to control blood loss.During the injection process, leaking from the balloon was noted and the balloon failed to inflate.The physician removed the balloon and noted that it was ruptured.A new balloon was placed to complete the procedure, and hemostasis was achieved.The patient was said to have minimal blood loss after the balloon rupture.No transfusion of any blood products was needed for the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: customer (person) street = (b)(6).Postal code = (b)(6).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 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

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

Manufacturer Narrative

Investigation evaluation it was reported that a the balloon of a 'bakri tamponade balloon catheter' ruptured after placement.The 'bakri' device was required for a patient post-cesarean delivery for a postpartum hemorrhage of an estimated 850 ml blood loss.After suturing the cesarean section incision closed, the balloon was placed transvaginally to control blood loss.During the injection process, leaking from the balloon was noted and the balloon failed to inflate.The physician removed the balloon and noted that it was ruptured.A new balloon was placed to complete the procedure, and hemostasis was achieved.The patient was said to have minimal blood loss after the balloon rupture.No transfusion of any blood products was needed for the patient.As reported, the patient did not experience any adverse effects or require any additional procedures 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.The device was leak tested and a small hole in balloon material near distal glue bond 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.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 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 by the returned device, a leak test was performed that identified a small hole in balloon material near distal glue bond.A review of the device history record found no related anomalies and no other complaints have been reported for the lot.A review of manufacturing procedures found controls to be in place to assure functionality and device integrity prior to shipping.A definitive cause of the hole in the balloon 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: 18265873
• MDR Text Key: 329720733
• Report Number: 1820334-2023-01623
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)250727(10)14863603
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• 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: 14863603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• 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