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	03/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary the fortrex 0.035in otw pta balloon catheter was received for evaluation.The fortrex balloon catheter was received with the balloon chamber in a post-inflation profile.All components of the fortrex balloon were accounted for.A 10cc water filled syringe was attached to the proximal hub luer lock of the y-manifold and the guidewire lumen was flushed: a clear steady stream of fluid was observed exiting the distal tip of the catheter.A 0.035¿ guidewire was loaded through the distal tip of the catheter and was able to navigate the full length of the catheter with ease.A 10cc water filled syringe was attached to the inflation lumen luer lock on the y-manifold and a vacuum was pulled: the vacuum could not be maintained.The 10cc water filled syringe attached to the inflation lumen luer lock on the y-manifold was lightly pressurized: a pinhole leak in the balloon chamber was noted.
Event or Problem Description
The physician was attempting to use a fortrex pta balloon to open up an iliac stent.The device was removed from its packaging and prepped per the ifu with no issues noted.It was reported that the balloon burst at 7atm pressure.The balloon was retrieved in full and no patient injury was reported.It was reported that the stent strut caused the balloon to burst.The physician completed the procedure successfully with no intervention needed.No patient injury was reported.
Additional Manufacturer Narrative
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: 6571319
• Report Number: 2183870-2017-00211
• Device Sequence Number: 616297
• Product Code: LIT
• UDI-Device Identifier: 00821684057902
• UDI-Public: 00821684057902
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 04/17/2017

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: 07/12/2019
• Device Catalogue Number: A35HPV12080080
• Device Lot Number: A308736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: 04/17/2017
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1