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

Catalog Number J-SOS-100500

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2018

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 (b)(6)-year-old female patient with natural labor experienced puerperal hemorrhage due to coagulation disorders.The bakri tamponade balloon catheter was used to stop the bleeding.The amount of bleeding reached 500 ml before placing this device.The physician held the balloon with a pair of forceps and placed it into the uterine cavity through the vagina then filled it out with 350 ml water adding 50 ml at a time.The physician heard a slight explosion and large amounts of liquid flowed out from the vagina.The physician removed the balloon and found the balloon was ruptured in a longitudinal direction.The physician used gauze packing to stop the bleeding successfully.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation a visual inspection of the returned device was conducted.The investigation also included review of complaint history, the device history record, instructions for use, manufacturing instructions, quality control data, specifications, and trends.One device was returned for investigation.A visual examination noted the returned device is split approximately 5mm from the distal end up to 5 mm from the proximal end for a total length of 6.5 cm.A review of the device history record found no non-conformances related to the failure mode of balloon rupture.A review of complaint history revealed this complaint to be the only complaint associated to lot number 8283420.The instructions for use provides the following warnings and precautions: warnings: the balloon should be inflated with a sterile liquid such as sterile water, sterile saline, or lactated ringers solution.The balloon should never be inflated with air, carbon dioxide or any other gas.The maximum inflation is 500ml.Do not overinflate balloon.Overinflation of the balloon may result in the balloon being displaced into the vagina.Precautions: avoid excessive force when inserting the balloon into the uterus.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The product was returned and the rupture was confirmed.The cause of the rupture could not be determined.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: 7341230
• MDR Text Key: 103014441
• Report Number: 1820334-2018-00471
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)201011(10)8283420
• 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: 05/10/2018

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 Catalogue Number: J-SOS-100500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 05/09/2018
• Supplement Dates FDA Received: 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 55