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

Catalog Number J-SOS-100500

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2020

Event Type  malfunction  

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, following a vaginal delivery, a bakri tamponade balloon catheter was used to treat a post-partum hemorrhage and began to leak.The user continued using the device to complete the procedure.No adverse effects have been reported due to this occurrence.Additional information regarding event details has been requested but is not available at this time.

Event Description

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

Manufacturer Narrative

Event summary: as reported, following a vaginal delivery, a bakri tamponade balloon catheter was used to treat a post-partum hemorrhage and began to leak.The user continued using the device to complete the procedure.No adverse effects have been reported due to this occurrence.Investigation - evaluation.Reviews of the instructions for use, manufacturing instructions, specifications, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.One bakri postpartum balloon catheter was returned for investigation in a used condition.No damage was visible on the catheter.A functional test was performed by inflating the balloon with tap water.A leak was observed from the distal sideport.Lumen communication within the stylet lumen caused the device to leak.A document-based investigation evaluation was performed.A review of the device history record and complaint history could not be completed due to lack of lot information from the user facility.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 manufacturing instructions, 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 500ml.Do not overinflate the balloon.Overinflation of the balloon may result in the balloon being displaced in the vagina.¿ the ifu also cautions, ¿avoid excessive force when inserting the balloon into the uterus.¿ based on the available information, cook has concluded that a definitive cause of the lumen communication discovered during the physical examination could not be established.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.

• 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: 10596524
• MDR Text Key: 208953376
• Report Number: 1820334-2020-01764
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• PMA/PMN Number: K170622
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1