BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO ELITE

    MDR report key: 2182888 · Received July 6, 2011

    Report

    Report Number
    2182888
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 6, 2011
    Manufacturer
    SPECTRANETICS CORP
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TURBO ELITE CATHETER WOULD NOT PASS OVER 0.014" GUIDEWIRE. AT THE HUB AREA, WIRE PASSED THROUGH WHEN BACK LOADED BUT WAS TIGHT. NEW LASER CATHETER WAS OPENED AND USED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBO ELITE CATHETER, REMOVAL, EXCIMER, ELECTRODE MCW SPECTRANETICS CORP 414-151 F11C14E

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR