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

Catalog Number	A35HPV07040080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2017
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 employed the use of a 7 mm fortrex pta balloon catheter and a mdt inflation device for a fistuloplasty procedure.A 6 fr non-medtronic sheath was used.Embolic protection was not used.Ifu was followed.This device was not passed through a previously deployed stent.Normal vessel size was 8 mm, target lesion narrowed to 3 mm.A 4 mm fortrex balloon had already been used on the lesion prior to this 7 mm fortrex balloon.It was reported that the 7 mm fortrex balloon burst during the procedure (burst occurred during gradual inflation at a pressure of 16 atm).The balloon did not break into fragments and was removed intact when pulling out the catheter.The physician post-dilated the lesion using a size 6 mm in.Pact admiral balloon.No patient injury was reported.Patient is reported as being stable.There were no intervention required.
Additional Manufacturer Narrative
Device evaluation summary: the fortrex 0.035in otw pta balloon catheter was received for evaluation.The balloon chamber of the balloon catheter was examined: a longitudinal tear was noted.All components of the balloon catheter 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: 7040021
• Report Number: 2183870-2017-00509
• Device Sequence Number: 13767133
• Product Code: LIT
• UDI-Device Identifier: 00821684057575
• UDI-Public: 00821684057575
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K142654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2018

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: 02/23/2019
• Device Catalogue Number: A35HPV07040080
• Device Lot Number: A232649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 02/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR