MAUDE Adverse Event Report: COVIDIEN TRAILBLAZER SUPPORT CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	SC-018-135
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the trailblazer catheter was received for evaluation.The nitrex guidewire was returned with the trailblazer catheter.No procedural reports or cine images from the procedure were received.On inspection of the trailblazer catheter, it was noted that distal end of the catheter was damaged and that some components of the catheter were not returned with the device.The catheter portion containing the three radiopaque markers on the distal segment of the catheter were not returned with the devices.The trailblazer catheter exhibited torsional twisting, tensile stretch, undulation, and catheter separation proximal of the proximal marker band.The distal segment of the trailblazer catheter was not returned with the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician attempted to use a nitrex guidewire (0.018" 300cm) and a trailblazer (0.018" 135cm) with a 6fr non-medtronic sheath to the left mid posterior tibial artery with 90% stenosis.The lesion length was reported as 65mm.Embolic protection was not used.The vessel was pre-dilated with a 2.5x80mm balloon at 8atm.No abnormalities were reported in relation to the patients anatomy.The devices were prepped as per the ifu.During the procedure the guidewire was inflated and squeezed into the support catheter.The structure of the guidewire was reported to be ¿broken¿, so both devices were completely removed from the patient.The procedure was completed successfully using a non-medtronic 0,014¿ 300cm guidewire and a 0,014¿ 150cm trailblazer.The lesion was post dilated with a 4x80mm balloon at 8atm.No patient injury was reported.

• Brand Name: TRAILBLAZER SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7662445
• Report Number: 2183870-2018-00370
• Device Sequence Number: 1980100
• Product Code: DQY
• UDI-Device Identifier: 00821684073919
• UDI-Public: 00821684073919
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K092299
• 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): 07/04/2018

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: 10/27/2018
• Device Catalogue Number: SC-018-135
• Device Lot Number: A350358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 07/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR