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	11/07/2017
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
The physician was attempting to use a fortrex pta balloon catheter to treat a 30mm severely calcified fibrous lesion in the left proximal brachial artery.The artery was 7mm in diameter, had moderate tortuosity and had 80% stenosis.The procedure used a 6 fr non-medtronic sheath and a 0.035" non-medtronic guidewire.The device was prepped as per the ifu with no issues identified.No pre-dilation of the vessel was performed.The physician encountered no resistance during the advancement of the device and no excessive force was used.The balloon was inflated using a medtronic ac3205p inflation device with contrast fluid.It was reported that during the first inflation, the balloon burst longitudinally at 20atms, after 55 seconds.The balloon material was reported to remain intact and no fragments were missing.Another fortrex balloon catehter was used to complete the procedure with no further issues.No patient injury was reported.

• 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: 7089962
• Report Number: 2183870-2017-00545
• Device Sequence Number: 16439649
• Product Code: LIT
• UDI-Device Identifier: 00821684057575
• UDI-Public: 00821684057575
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Report Date (Section B): 12/06/2017

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: 03/07/2019
• Device Catalogue Number: A35HPV07040080
• Device Lot Number: A238758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1