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

Catalog Number	A35HPV12080080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a fortrex balloon during treatment of a fibrous fistula in mid location of the patient¿s vessel.Slight tortuosity and no calcification were reported.No damage was noted to the packaging, nor were any issues experienced when removing the device from the packaging.The ifu was followed and the device was prepped without issue.A non-medtronic inflation device was used.The device was not passed through a previously deployed stent.No resistance was encountered when advancing the device.It was reported that a balloon burst occurred at an inflation pressure of 12atm.It is unknown how many prior inflations were applied to the device.The device was removed from the patient and the procedure was aborted.The burst did not cause any portion of the balloon to fragment.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: a single photograph of the device removed from the patient was received.The fortrex 0.035in otw pta balloon catheter was not received.No ancillary devices or cine images from the procedure were received for evaluation.The photograph is of the fortrex balloon catheter removed from the patient and support catheter.A small amount of the proximal balloon chamber cone remains proximal of the proximal radiopaque marker band.The balloon chamber material appears to be bunched up over the distal radiopaque marker band.The distal tip of the fortrex balloon catheter is present.The bunched-up balloon chamber material appears to have both radial and longitudinal tearing.Based on the photograph, all components are accounted for.If information is provided in the future, a supplemental report will be issued.

• 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: 8109767
• Report Number: 2183870-2018-00537
• Device Sequence Number: 11328206
• Product Code: LIT
• UDI-Device Identifier: 00763000106430
• UDI-Public: 00763000106430
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

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: 10/03/2021
• Device Catalogue Number: A35HPV12080080
• Device Lot Number: A718620
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1