BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIANCE

    MDR report key: 6089129 · Received November 9, 2016

    Report

    Report Number
    6089129
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    July 11, 2016
    Report Date
    September 30, 2016
    Manufacturer
    EV3, INC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TIP OF WIRE BROKE OFF INSIDE PT'S ARTERY OF THE LEFT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740084 VIANCE CATHETER, PERCUTANEOUS DQY EV3, INC A213711

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other