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

Model Number G30673

Device Problem Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, during treatment of a postpartum hemorrhage (pph), a bakri tamponade balloon catheter ruptured.The device was placed with the assistance of sponge forceps.400ml of saline was injected into the balloon, and the device was found ruptured.The procedure was completed by using another same type device.No adverse events have been reported as a result of the alleged malfunction.Additional information has been requested regarding the patient and the event.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, during treatment of a postpartum hemorrhage (pph), a bakri tamponade balloon catheter ruptured.The device was placed with the assistance of sponge forceps.400ml of saline was injected into the balloon, and the device was found ruptured.The patient lost approximately 1000ml of blood before the device was placed and 600ml after it was placed.The procedure was completed by using another same type device.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, specifications, and quality control procedures and a visual inspection of the device were conducted during the investigation.One bakri postpartum balloon catheter was returned for investigation.Visual examination confirmed the catheter was returned in a used condition.The stopcock was missing from the inflation line, and the balloon was ruptured.A puncture mark was identified in the split area on the balloon.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device specifications or quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use, which warn, ¿the maximum inflation is 500 ml.Do not overinflate the balloon.Overinflation of the balloon may result in the balloon being displaced into the vagina.¿ the ifu further cautions, ¿avoid excessive force when inserting the balloon into the uterus.¿ based on the available information, cook has concluded that the puncture marks observed on the returned balloon were likely caused by sponge forceps during placement of the device.The most probable cause of the reported event was determined to be unintended user error.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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.

Event Description

The patient lost approximately 1000ml of blood before the device was placed and 600ml after it was placed.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10575214
• MDR Text Key: 208190877
• Report Number: 1820334-2020-01742
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)220808(10)9936158
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2022
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 9936158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Weight: 53