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

Model Number G30673

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

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

It was reported, upon opening the package of a bakri tamponade balloon catheter for use in treatment of post partum hemorrhage, the operator noted the device to be broken and leaking.The leak was discovered during visual examination prior to use on the patient.Approximately 800ml of blood was lost prior to the second bakri placement.Another bakri device was used to achieve hemostasis.No adverse effects have been reported due to the alleged malfunction.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Ec method code desc - 5: communication/interviews (4111).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, specifications, trends, communication/interviews, and quality control data.One device was returned for investigation.Visual examination confirmed the catheter was returned clean.The stopcock was attached to the inflation line and noted to be in the open position.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 material.Under magnification, graspers marks were observe on the balloon material.Beneath the marks, the balloon had been punctured and caused the leak.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related 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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied upon removal from the package, inspect the product to ensure no damage has occurred.The cause of the balloon leakage could not be determined.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.

Event Description

No additional patient or event information has been received since the last report was submitted on 13nov2019.

• 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: 9314756
• MDR Text Key: 190689695
• Report Number: 1820334-2019-02858
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)211115(10)9316164
• Combination Product (y/n): N
• 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: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2021
• Device Model Number: G30673
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 9316164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1