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

Model Number G30673

Device Problem Material Puncture/Hole (1504)

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

Event Date 06/03/2019

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Pma/510k # k170622.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

After a natural delivery, a bakri tamponade balloon catheter was placed with sponge forceps.The balloon was inflated up to 200 ml when a leak was first noticed.The balloon was removed right away and a inflation test was conducted in vitro.A pinhole was found on the balloon material.Another bakri device was then opened and used to complete the procedure.No adverse effect to the patient has been reported due to this event.Additional information has been requested and a follow-up report will be submitted when/if that information is received.

Event Description

No new patient or event information since the last report was submitted on (b)(6) 2019.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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, device history record, the instructions for use, quality control data, and specifications.One packaging tray that contained a bakri postpartum balloon catheter was returned for investigation.Visual examination confirmed the catheter and syringe were returned in used condition.Dried residue was observed inside of the balloon.A functional test was performed on the open device by inflating the balloon with 150ml of tap water.A leak was confirmed in the balloon.Under magnification, puncture marks were observed on the balloon material.One of the puncture marks penetrated the material causing the balloon to leak.A review of the device history record found no non-conformances.Because there are no non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warns the maximum inflation is 500ml.Do not overinflate the balloon.Balloon should be inflated with sterile liquid.Balloon should never be inflated with air, carbon dioxide or any gas.The ifu also precautions to avoid excessive force when inserting the balloon into the uterus.How supplied "upon removal from the package, inspect the product to ensure no damage has occurred." the complaint was confirmed based on customer testimony and evaluation of the returned device.Based on the available information, the most likely cause of the event was determined to be unintended use error.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database 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.

• 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: 9033341
• MDR Text Key: 158708658
• Report Number: 1820334-2019-02309
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)200724(10)8087300
• Combination Product (y/n): N
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2020
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 8087300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Date Manufacturer Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 82