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

Model Number	SC-035-090
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: the trailblazer catheter was received in two segments and exhibited witness mark consistent of the distal tip being recovered by a snare, (e.G.The kink just proximal of the distal radiopaque marker band).The segments were separated proximal of the proximal marker band; approximately 80.5cm distal of the printed strain relief distal tip.The distal segment included all three radiopaque marker bands.All components of the trailblazer were accounted for.The working length of the returned catheter measures approximately 94cm (85cm to 95cm per design).Just proximal to the distal marker band was a kink.The separation faces exhibited tensile stretching, rotational stretching and bending.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a trailblazer support catheter to treat a lesion in the sfa.The artery had a diameter of 6-7 mm with little tortuosity.No abnormalities were reported in relation to the patient¿s anatomy.The device was prepped as per the ifu.The thumb screw/ lock-pin was checked for securement prior to the procedure.A 6 fr sheath and 0.035" guidewire was used in the procedure, no embolic protection was used.The vessel was not pre-dilated.The physician was met with resistance during advancement but no excessive force was used.It was reported that the catheter got caught in the external/ common iliac artery and was unable to cross the lesion.The catheter had passed through a previously deployed unknown self-expanding stent.The tip of the trailblazer detached and it had to be retrieved using a gooseneck snare.The procedure was completed using a 5 fr catheter and a new trailblazer.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: 6905087
• Report Number: 2183870-2017-00423
• Device Sequence Number: 19128131
• Product Code: DQY
• UDI-Device Identifier: 00821684073940
• UDI-Public: 00821684073940
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/01/2017

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: 05/18/2020
• Device Model Number: SC-035-090
• Device Catalogue Number: SC-035-090
• Device Lot Number: A462832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 09/29/2017
• 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: 81 YR