MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problems Balloon rupture (1049); Material Rupture (1546)

Patient Problems Foreign body, removal of (2365); No Code Available (3191)

Event Date 12/05/2014

Event Type  Injury  

Event Description

Upon ballooning, the balloon ruptured on the plaque and broke off into multiple pieces.Pieces had to be snared out.Imaging did not show any remaining pieces.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Investigation a review of complaint history, instructions for use (ifu), quality control, trends, and a visual inspection of the returned device were conducted during the investigation.One balloon catheter was returned for investigation.A visual examination of the device noted the balloon ruptured circumferentially.The tip material broke off the catheter and the balloon was broken into 3 pieces.The ifu, states under the warnings heading, ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.Do not use a power injector for balloon inflation.Rupture may occur.¿ the balloon is designed to burst longitudinally which minimizes the risk of balloon and/or catheter separation upon devices withdrawal.Detection activities have been conducted; the reason for this failure cannot be determined.We will notify the appropriate internal personnel and continue to monitor for similar complaints.

Event Description

Upon ballooning, the balloon ruptured on the plaque and broke off into multiple pieces.Pieces had to be snared out.Imaging did not show any remaining pieces.

Manufacturer Narrative

(b)(4).

Event Description

Upon ballooning, the balloon ruptured on the plaque and broke off into multiple pieces.Pieces had to be snared out.Imaging did not show any remaining pieces.

• Brand Name: ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4377103
• MDR Text Key: 5238442
• Report Number: 1820334-2015-00006
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2017
• Device Model Number: N/A
• Device Catalogue Number: PTAX4-18-170-6-10
• Device Lot Number: 5335974
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/05/2014
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2014
• 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
• Patient Age: 83 YR