MAUDE Adverse Event Report: COOK, INC. ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; CATHETER, PERCUTANEOUS

Catalog Number PTA4-18-80-3-4

Device Problems Material Separation (1562); Device, removal of (non-implant) (2608)

Patient Problem Surgical procedure, additional (2564)

Event Date 02/11/2015

Event Type  malfunction  

Event Description

When inflating a 3mm balloon in a tight iliac lesion on a male pt, there appeared to be waisting in the middle of the balloon.The balloon was deflated and pulled back.At this point, it was identified that the balloon had become detached from the catheter.The catheter was removed and retrieval of the balloon was carried out.This did not adversely effect the pt however the duration of the procedure was increased considerably due to this incident.

Manufacturer Narrative

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

• Brand Name: ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4605888
• MDR Text Key: 5629182
• Report Number: 1820334-2015-00065
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2017
• Device Catalogue Number: PTA4-18-80-3-4
• Device Lot Number: 5154679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2015
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2014
• 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
• Patient Outcome(s): Required Intervention