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

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 11/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported the physician placed the balloon with 150 cc of fluid, but only 60 cc of fluid was aspirated when he attempted to remove it from the patient 24 hours later.Reportedly bleeding was arrested.The physician suspected the fluid leaked from the proximal side of the balloon or the catheter little by little.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: one bakri tamponade balloon catheter device was returned for investigation.A functional test was performed.The balloon was inflated with water and a leak was noted at the proximal glue bond.Complaint was confirmed based on testing of the returned device.Based on the information provided, the actual root cause was unable to be determined.A review of production and quality documentation did not observe any specific issues with current controls that may have contributed to this incident.A review of the device history records for this product revealed there were no non-conformances during the manufacturing process that would have caused or contributed to the reported issue.A review of complaint history for this product/lot number combination revealed this complaint to be one of three complaints associated with complaint lot number 7327725.One complaint was for a similar issue; the balloon would not inflate due to a pinhole in it.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: BAKRI TAMPONADE BALLOON CATHETER
• Type of Device: OQY INTRAUTERINE BALLOON
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6202411
• MDR Text Key: 63231583
• Report Number: 1820334-2016-01545
• Device Sequence Number: 1
• Product Code: OQY
• UDI-Device Identifier: 10827002306735
• UDI-Public: (01)10827002306735(17)190623(10)7071546
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-SOS-100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1