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

Catalog Number	A35HPV04040080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the fortrex 0.035in otw pta balloon catheter was received for evaluation.The fortrex balloon catheter was examined and all components were accounted for.A 10cc water filled syringe was attached to the proximal hub luer lock and the guidewire lumen was flushed until clear fluid ran freely from the distal end of the catheter.A 0.035¿ guidewire was loaded with ease through the distal tip of the catheter and navigated its full length out the proximal hub luer lock.A 20cc water filled syringe with manometer was attached to the inflation lumen lock the balloon catheter would not hold pressure.Sanguine fluid was observed exiting the side of the balloon chamber.Upon closer examination it was noted that the balloon chamber had a longitudinal tear.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a fortrex pta balloon catheter to dilate an existing stent in the sfa.The lesion was a 40 mm moderately calcified plaque lesion in the right proximal sfa (80% stenosis).The artery had little tortuosity and was 5 mm in diameter.The device was prepped as per the ifu with no issues identified.The procedure used a 6 fr non-medtronic sheath and a 0.035" 260 cm non-medtronic guidewire.No resistance was encountered advancing the device and no excessive force was used.A non-medtronic inflation device was used with 50/50 contrast and normal saline.It was reported that the balloon ruptured at 22 atm pressure.No patient injury was reported.The procedure was completed by using another fortrex balloon.

• 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: 7236527
• Report Number: 2183870-2018-00056
• Device Sequence Number: 1017946
• Product Code: LIT
• UDI-Device Identifier: 00821684057216
• UDI-Public: 00821684057216
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2018

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: 04/08/2019
• Device Catalogue Number: A35HPV04040080
• Device Lot Number: A257643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 95