BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERCROSS

    MDR report key: 4273219 · Received October 2, 2014

    Report

    Report Number
    4273219
    Event Type
    Malfunction
    Date Received
    October 2, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 2, 2014
    Manufacturer
    EV3, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON WAS FOUND SHREDDED UPON REMOVAL FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614458 EVERCROSS CATHETER, PERCUTANEOUS DQY EV3, INC. * 9540534

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR NO OTHER THERAPIES