BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRAGE .008" HYDROPHYLIC GUIDEWIRE

    MDR report key: 2972214 · Received February 21, 2013

    Report

    Report Number
    2029214-2013-00158
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 23, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GUIDEWIRE WAS RETURNED AND THE COREWIRE WAS FOUND BROKEN INTO TWO SEGMENTS. ANALYSIS OF THE CROSS SECTION AT THE BREAK POINT SHOWED THE FAILURE OF THE COREWIRE OCCURRED DUE TO DUCTILE OVERLOAD.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A DURAL FISTULA. DURING THE PROCEDURE, IT WAS REPORTED THAT THE MIRAGE GUIDEWIRE COULD NOT BE PULLED OUT OF THE ULTRAFLOW CATHETER SO IT WAS DECIDED TO WITHDRAW BOTH OF THEM AT THE SAME TIME. UPON WITHDRAWAL, THE DISTAL END OF THE CATHETER AND GUIDEWIRE SEPARATED AND REMAINED IN THE PATIENT.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.SAME EVENT AS MDR# 2029214-2013-00157.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76822 MIRAGE .008" HYDROPHYLIC GUIDEWIRE GUIDEWIRE DQX EV3 NEUROVASCULAR 103-0608 9624230

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability