MAUDE Adverse Event Report: COOK INC BAKRI TAMPONADE BALLOON CATHETER; KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC

Model Number N/A

Device Problem Burst Container or Vessel (1074)

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 12/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

Customer reported a patient experienced uncontrolled postpartum hemorrhaging.The attending physician attempted to control the uterine hemorrhaging with a bakri tamponade balloon catheter.The customer reported that the balloon burst after instilling 200 ml of an expected 500 ml total volume.According to the initial reporter, the patient experienced adverse effects due to this occurrence.The physician placed a second bakri in place to control the bleeding.No further information was provided.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, quality control and visual inspection of the returned device was conducted during the investigation.The balloon catheter was returned in two segments.The segment included the hub and measured 39.5 cm in length.The balloon segment measured 5 cm in length.A visual examination noted the balloon material had a ¿u¿ shaped tear in it.An unknown sticky residue was also noted on the catheter 2 cm from the distal tip.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: KNA INSTRUMENT, MANUAL, SPECIALIZED, OBSTETRIC-GYNECOLOGIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6279602
• MDR Text Key: 65838824
• Report Number: 1820334-2017-00061
• Device Sequence Number: 1
• Product Code: KNA
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)191020(10)7376301
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2017

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SOS-100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2017
• Initial Date FDA Received: 01/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2016
• 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