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

Model Number G30673

Device Problem Material Rupture (1546)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/04/2022

Event Type  Injury  

Event Description

As reported, during treatment of a post-partum hemorrhage, a bakri tamponade balloon catheter ruptured.The patient lost 900ml of blood before the device was inserted and inflated with 400ml saline.The device was not handled by any metal tools.After indwelling for 12 hours, the patient heard a rupture sound followed by an outflow of fluid.The device was immediately removed from the patient.The patient lost 100ml of blood following device placement.As hemostasis was achieved following device removal, no additional intervention was required.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(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 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.

Manufacturer Narrative

Event summary as reported, during treatment of a post-partum hemorrhage, a bakri tamponade balloon catheter ruptured.The patient lost 900ml of blood before the device was inserted and inflated with 400ml saline.The device was not handled by any metal tools.After indwelling for 12 hours, the patient heard a rupture sound followed by an outflow of fluid.The device was immediately removed from the patient.The patient lost 100ml of blood following device placement.As hemostasis was achieved following device removal, no additional intervention was required.The patient did not experience any adverse effects due to this occurrence.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, and quality control procedures were conducted during the investigation.The device was not returned for investigation.A review of complaint history records shows one other related complaint 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.No related non-conformances were recorded for this lot.The device history record review provides objective evidence that the device was manufactured to specification.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided with instructions for use which caution, ¿avoid excessive force when inserting the balloon into the uterus.¿ the ifu further warns, "the bakri postpartum balloon is indicated for use in the event of primary postpartum hemorrhage within 24 hours of delivery." based on the available information, cook has concluded that the most probable cause of the reported event could not be determined.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per a review of risk documentation, 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

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

• 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: 15311936
• MDR Text Key: 298800562
• Report Number: 1820334-2022-01417
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)240510(10)13950951
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2024
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 13950951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 08/29/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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 Outcome(s): Life Threatening