BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    .008" MIRAGE GUIDEWIRE

    MDR report key: 703159 · Received April 24, 2006

    Report

    Report Number
    2029214-2006-00043
    Event Type
    Malfunction
    Date Received
    April 24, 2006
    Date of Event
    January 6, 2006
    Report Date
    March 16, 2006
    Manufacturer
    EV3 NEUROVASCULAR DIVISION
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE UNDERGOING A LENGTHY NEURO-INTERVENTIONAL PROCEDURE, THE MIRAGE GUIDEWIRE BROKE OFF AND WAS ABLET O BE RETRIEVED. NO COMPLICATIONS WERE REPORTED TO HAVE OCCURRED WITH THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 .008" MIRAGE GUIDEWIRE GUIDEWIRE DQX EV3 NEUROVASCULAR DIVISION 103-0608 1371956

    Patients

    Seq Age Sex Outcome Treatment
    1 24 DAY Required Intervention