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

Catalog Number	SC-035-090
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Photographic evaluation: the trailblazer catheter was not received for evaluation.Two photographic images of cine images were received.The two similar cine images showed a stent deployed radiopaque hoops, two trailblazer radiopaque markers that appear to be not on a guidewire, and a guidewire running through the targeted vessel.The cine images showed a trailblazer separated during the procedure.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician used a trailblazer support catheter to treat a severely calcified lesion having a chronic total occlusion (cto), in the superficial femoral artery.The artery diameter was reported to be 6mm and a lesion length of 200mm.It was reported the physician crossed the lesion with the trailblazer catheter, but encountered difficulty removing the catheter.The catheter broke, leaving 3 radio-opaque markers in the sfa.The procedure was completed using another catheter, and the lesion was ballooned and stented.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: 6984445
• Report Number: 2183870-2017-00472
• Device Sequence Number: 13558886
• Product Code: DQY
• UDI-Device Identifier: 00821684073940
• UDI-Public: 00821684073940
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092299
• 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): 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2020
• Device Catalogue Number: SC-035-090
• Device Lot Number: A498633
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 113