BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBOHAWK

    MDR report key: 3896663 · Received June 20, 2014

    Report

    Report Number
    3896663
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 20, 2014
    Manufacturer
    EV3
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE COULD NOT BE EXTRACTED AND BROKE OFF INSIDE OF PATIENT'S ARTERY RESULTING IN THE NEED TO GO IN AND REMOVE THE PIECE VIA SNARE. THEREFORE, THE SURGEON PERFORMED A RETRIEVAL FOREIGN BODY LEFT ILIAC ARTERY WITH SNARE RIGHT COMMON FEMORAL ENDARTERECTOMY AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363107 TURBOHAWK CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 THS-LX-C 9676944

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR