MAUDE Adverse Event Report: COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	A35HPV12040080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the fortrex 0.035in otw pta balloon catheter was received for evaluation.No ancillary devices or cine images from the procedure were received.The device was received in a post-inflation state.The exterior of the balloon chamber was covered with sanguine residue.A 10cc water filled syringe was attached to the proximal hub luer lock and the guidewire lumen was flushed: a steady stream of sanguine tinted fluid that turned clear was observed exiting the distal end of the dilatation catheter.A 0.035¿ guidewire was loaded through the distal tip of the dilatation catheter and navigated out the proximal hub with ease.A 10cc water filled syringe was attached to the inflation lumen of the y-manifold: a vacuum was able to be pulled and maintained.A 20cc water filled syringe with manometer was attached to inflation lumen of the y-manifold and the balloon chamber was inflated to its nominal pressure of 8atm.The dilatation catheter was able to maintain nominal pressure.The dilatation catheter was inflated to its rated burst pressure of 14atm.The dilatation catheter was able to maintain its rated burst pressure.A vacuum was drawn, and the balloon chamber was able to be fully deflated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It is reported a balloon burst occurred.No patient injury was reported.A different balloon was used to complete the procedure.

• Brand Name: FORTREX 0.035 OTW PTA BALLOON CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7933383
• Report Number: 2183870-2018-00455
• Device Sequence Number: 16378909
• Product Code: LIT
• UDI-Device Identifier: 00821684057872
• UDI-Public: 00821684057872
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2021
• Device Catalogue Number: A35HPV12040080
• Device Lot Number: A693010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1