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 11/19/2018

Event Type  malfunction  

Manufacturer Narrative

(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, the doctor inserted the bakri tamponade balloon catheter inside the uterus and attempted to inflate the balloon up to 300 cc using a 60cc syringe.During inflation, the doctor found the balloon was leaking.The balloon was deflated and removed and a second device was used.The second balloon also leaked.The doctor had to use third balloon to manage post partum hemorrhage (pph) and inflation was successful.No adverse events have been reported as a result of the alleged malfunction.

Event Description

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

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, the device history record, instructions for use, quality control data and trends.Two devices were returned for investigation.Device 1: functional testing was performed using a syringe and water.A leak was confirmed.Visual examination observed a pin hole in balloon material.Device 2: functional testing was performed using a syringe and water.A leak was confirmed.Visual examination observed the balloon material is cut where the device leaks.Both devices were found to leak.One device has a pin hole leak in the balloon material; the other device has a cut in balloon material where the device leaks.The balloon material appears to have come in contact with an undetermined sharp instrument.The device history record was reviewed and no non-conformances were identified that would be related to the reported failure.A complaint history search revealed this is the only complaint associated with lot number 9019248.A conclusion as to the cause of these events could not be established.Measures have been initiated to address this failure mode.Cook medical has notified the appropriate personnel and 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: 8133138
• MDR Text Key: 129891552
• Report Number: 1820334-2018-03512
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)210716(10)9019248
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2021
• Device Catalogue Number: J-SOS-100500
• Device Lot Number: 9019248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR