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

Catalog Number	A35HPV10080080
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the fortrex device was returned for evaluation.The device was loaded inside an introducer sheath.No other ancillary devices were included.Visual inspection: the fortrex and ancillary devices were inspected.Approximately 20cm of the guidewire was exposed outside the distal rim of the sheath.Approximately 64cm of the guidewire was exposed between the sheath and the distal end of the fortrex catheter.The tip of the catheter showed the material spiraled.The balloon showed a burst with the balloon material buckled at the proximal end.A marker band was identified at the proximal end of the balloon segment.The working length of the fortrex catheter was approximately 85cm.The product labeling indicates the working length is 80cm and there are two marker bands at the balloon segment.A marker band was discovered after pulling the guidewire from the sheath.Under microscope the fracture face of the distal end of the catheter shows the material stretched and twisted.Blue catheter material was discovered within the sheath hub.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was using a fortrex balloon to treat a 80mm moderately calcified axial artery lesion.The artery had a 10mm diameter and low tortuosity.The procedure used a 7 fr non mdt (bsc) sheath and a 0.035" non mdt (bsc glidewire).The device was prepped as per the ifu with no issues identified.The lesion was pre dilated.Contrast and saline inflation fluid was used with a non mdt (bsc) device.There was no resistance advancing the device and the device did not pass through a previously-deployed stent.Balloon burst at 16 atm during initial inflation.Burst balloon was unable to be retracted through sheath, so balloon, wire and sheath all had to be removed thus ending the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Product analysis: the fortrex device was returned for evaluation.A 0.033" guidewire was inserted into the fortrex which was loaded inside an introducer sheath.No other ancillary devices were received.The fortrex device and ancillary devices were removed from the pouch and inspected.Approximately 20cm of the guidewire was exposed outside the distal rim of the sheath and approximately 64cm of the guidewire was exposed between the sheath and the distal and of the fortrex catheter.The material on the tip of the catheter was spiralled.A radial balloon burst was observed and the balloon material was buckled at the proximal end.The working length of the fortrex catheter was approximately 85cm.A marker band was identified at the proximal end of the balloon segment and the other marker band was discovered after pulling the guidewire from the sheath.Under microscopic inspection, the material of the fracture face of the distal end of the catheter was stretched and twisted.Blue catheter material was discovered within the sheath hub.If information is provided in the future, a supplemental report will be issued.
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: 7585914
• Report Number: 2183870-2018-00325
• Device Sequence Number: 2292330
• Product Code: LIT
• UDI-Device Identifier: 00821684057841
• UDI-Public: 00821684057841
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 10/05/2018

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: 04/05/2021
• Device Catalogue Number: A35HPV10080080
• Device Lot Number: A625414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 06/19/2018; 08/08/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 07/17/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR