BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COURIER GUIDEWIRE

    MDR report key: 1968540 · Received December 23, 2010

    Report

    Report Number
    3006010712-2010-00028
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    September 22, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BRIVANT LTD
    Product Code
    DQX
    PMA / PMN Number
    K073082
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TO ASSIST IN ROOT CAUSE DETERMINATION, SEM ANALYSIS IS ROUTINELY CARRIED OUT ON THE FRACTURE SURFACE WHERE THERE ARE INCIDENTS OF FRACTURED GUIDEWIRE. SEM HAS BEEN SCHEDULED FOR WEEK 2 IN 2011 FOLLOWING WHICH, WE WILL COMPLETE OUR INVESTIGATION AND SUBMIT A F/U REPORT.

    Description of Event or Problem · 1

    THE TIP OF THE WIRE BROKE DURING PULL OUT THE WIRE OF THE CS TARGET VEIN. THE TIP IS LEAVING INTO THE CS VEIN SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COURIER GUIDEWIRE GUIDEWIRE DQX BRIVANT LTD DS2G001 90015315

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN