BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANALIZER GUIDEWIRE .035 X 150CM

    MDR report key: 1648353 · Received March 25, 2010

    Report

    Report Number
    1036710-2010-00006
    Event Type
    Malfunction
    Date Received
    March 25, 2010
    Date of Event
    December 17, 2009
    Report Date
    December 18, 2009
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    DQX
    PMA / PMN Number
    K050873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THE SAMPLE FOR REVIEW. THE SAMPLE WAS SENT TO OUR SUPPLIER, THE MANUFACTURER, OF THE CANALIZER WIRE FOR FURTHER INVESTIGATION INTO THE ROOT CAUSE OF THE REPORT. THE FIRST 5 TO 10 INCHES OF THE COATING WAS PEELED OFF. THERE ARE DAMAGES IN SEVERAL OTHER PLACES ON THE WIRE ALSO. THE PIECE THAT PEELED OFF IS SPLIT THROUGH. THE INNER CORE IS BENT IN A WAY WHICH IS INDICATIVE OF SOMETHING SHARP SCRAPING THE WIRE WHILE IT WAS BENT DURING THE PROCEDURE. BASED ON THE FINDING THE SUPPLIER DETERMINED THAT THE COATING DETACHED DUE TO HEAVY-HANDED TREATMENT. THEY REVIEWED RELATED PRODUCTION HISTORY FILES AND NO QUALITY ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS OR WHEN THE PRODUCT WAS RELEASED. OUR DFU STATES MISUSE OF THIS GUIDEWIRE COULD RESULT IN DAMAGE OR ABRASION OF THE HYDROPHILIC COATING ON THE OUTER SURFACE, AND/OR BREAKAGE/SEPARATION/CUTTING ON THE OUTER COVERING WHICH MAY NECESSITATE REMOVAL OR RETRIEVAL. IT ALSO STATES TO PREVENT DAMAGE TO THE VASCULATURE, BREAKAGE/SEPARATION/CUTTING OF THE GUIDEWIRE AND CATHETER DAMAGE, ALWAYS MANIPULATE CAREFULLY AND SLOWLY WHILE CONFIRMING THE MOTION AND LOCATION OF THE GUIDEWIRE TIP UNDER FLUOROSCOPY.

    Description of Event or Problem · 1

    CASE WAS A D COT ON DIALYSIS GRAFT. THE HYDROPHILIC COATING BUNCHED UP AND WAS STRIPPED ON WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANALIZER GUIDEWIRE .035 X 150CM VASCULAR GUIDEWIRE DQX ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 127635150 92671WZE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other