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

Model Number G30673

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: non-healthcare professional.Pma/510k # k170622.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that a bakri tamponade balloon catheter was placed to treat post-partum bleeding in a patient who had a cesarean section delivery at 36w+5d due to marginal placenta previa.Prior to the balloon placement, the patient had 300ml blood loss and was treated with carboprost tromethamine injection.The balloon was then place in the incision of the cesarean section, and the uterus was sutured.Upon instillation of fluid into the balloon, leaking was found in the front part of the balloon through a pin hole.The balloon was immediately removed and another balloon was used to achieve homeostasis.No adverse events have been reported as a result of the alleged malfunction.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: concomitant medical products.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, quality control data, and trends.One device was returned for investigation.Functional testing notes the balloon leaks.There is a cut in the balloon material where the leak occurred.A review of the device history record for lot number lot 9100167 showed no non-conformances.A review of complaint history revealed no other complaint associated with lot #lot 9100167.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: instructions: 4.Close the incision per normal procedure, taking care to avoid puncturing the balloon while suturing.Note: ensure that all product components are intact and the hysterotomy is securely sutured prior to inflating the balloon.If clinically relevant, the abdomen may remain open upon inflation of the balloon to closely monitor uterine distention and confirm the hysterotomy closure.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The complaint was confirmed based on evaluation of the returned device.It was determined that the bakri balloon was most likely punctured during the closure of the caesarean section.The cause of the event was traced to the user and determined to be a failure to follow instructions.Per the quality engineering risk assessment, no further action is warranted.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

There has been no new event information received since the last report was submitted.

• 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: 8377867
• MDR Text Key: 138423410
• Report Number: 1820334-2019-00527
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)210816(10)9100167
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2021
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 9100167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARBOPROST TROMETHAMINE
• Patient Age: 35 YR