BEUDAMED
    FDA Adverse Event Other Summary report: N

    TURBOHAWK LS-C

    MDR report key: 1510268 · Received October 15, 2009

    Report

    Report Number
    MW5013021
    Event Type
    Other
    Date Received
    October 15, 2009
    Date of Event
    September 29, 2009
    Report Date
    October 5, 2009
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SEVERAL PASSES MADE WITH THIS CATHETER IN LEFT COMMON FEMORAL. WHEN TRYING TO REMOVE CATHETER (FOR CLEANING) PURPOSES, CATHETER WAS NOTED TO HAVE TIP BROKEN OFF IN SHEATH. DID HAVE DIFFICULTY INSERTING CATHETER THROUGH 7FR PINNACLE SHEATH. NO PT HARM NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBOHAWK LS-C ATHERECTOMY CATHETER MCW EV3 INC. THS-LS-C *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other