BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    .008" MIRAGE HYDROPHYLIC GUIDEWIRE

    MDR report key: 2873761 · Received December 14, 2012

    Report

    Report Number
    2029214-2012-00720
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 15, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GUIDEWIRE WAS RETURNED WITH THE COREWIRE IN TWO BROKEN SEGMENTS. ANALYSIS OF THE CROSS SECTION AT THE BREAK POINT SHOWED THE FAILURE OF THE COREWIRE OCCURRED DUE TO TORSIONAL OVERLOAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A DURAL FISTULA. DURING THE PROCEDURE, IT WAS REPORTED THAT THE MIRAGE GUIDEWIRE BROKE AT THE END OF THE RADIOPAQUE SEGMENT. THE BROKEN SEGMENT WAS EASILY RETRIEVED FROM THE PATIENT SINCE IT BROKE INSIDE THE APOLLO CATHETER. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 .008" MIRAGE HYDROPHYLIC GUIDEWIRE GUIDEWIRE DQX EV3 NEUROVASCULAR 103-0608 9546776

    Patients

    Seq Age Sex Outcome Treatment
    1