BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATUSI GUIDEWIRE

    MDR report key: 769940 · Received September 18, 2006

    Report

    Report Number
    2954740-2006-00007
    Event Type
    Malfunction
    Date Received
    September 18, 2006
    Date of Event
    August 1, 2006
    Report Date
    September 8, 2006
    Manufacturer
    MICRUS ENDOVASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH WE CANNOT FIND ANY PHYSICAL FAULT WITH THE WATUSI GUIDEWIRE, VISUAL AND FUNCTIONAL TESTING OF THE INSERTION TOOL ACCESSORY DID REVEAL SOME ROUGHNESS AROUND THE PROXIMAL AND DISTAL TIP OF THE HYPOTUBE USED IN THE INSERTION TOOL. THIS RESULTED IN THE SCRAPED COATING FROM THE GUIDEWIRE. SUBSEQUENT TESTING PRODUCED THIS RESULT ONLY IF THE GUIDEWIRE WAS INSERTED BEYOND A 15 DEGREE ANGLE.

    Description of Event or Problem · 1

    PHYSICIAN NOTED A LOOSE FILAMENT HANGING DOWN FROM THE GUIDEWIRE AS HE WAS ABOUT TO PUT IN THE GUIDEWIRE FOR AN NTH TIME (N BETWEEN 1 AND 4, BUT NOT=1). HE THOUGHT THAT IT HAD COME FROM THE GUIDEWIRE. NOTE: UPON RETURN, IT WAS DETERMINED THAT A SECTION OF THE COATING HAD BEEN SCRAPED OFF THE GUIDEWIRE, THUS THE LOOSE FILAMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WATUSI GUIDEWIRE GUIDEWIRE DQX MICRUS ENDOVASCULAR WST UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN