BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVITAS CTO GUIDEWIRE

    MDR report key: 2064058 · Received March 22, 2011

    Report

    Report Number
    3006010712-2011-00030
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2010
    Report Date
    March 14, 2011
    Manufacturer
    BRIVANT LTD
    Product Code
    DQX
    PMA / PMN Number
    K060551
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ANALYSIS WILL BE SCHEDULED WHEN THE DEVICE IS RETURNED. WE WILL THEN COMPLETE OUR EVALUATION AND SUBMIT A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED ON (B)(6) 2011 WITH THE FOLLOWING TEXT: "BREAK THE WIRE TIP DURING RECANALIZATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVITAS CTO GUIDEWIRE GUIDEWIRE DQX BRIVANT LTD 102-000-000-BBR 90016977

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN