BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COURIER GUIDEWIRE

    MDR report key: 1812273 · Received August 16, 2010

    Report

    Report Number
    3006010712-2010-00015
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    December 6, 2010
    Report Date
    August 16, 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. INITIAL SEM WAS INCONCLUSIVE DUE TO THE POLYMER COATING ON THE DEVICE CONTAMINATING THE SURFACE FOLLOWING REMOVAL. FOLLOW UP SEM HAS BEEN SCHEDULED FOR WEEK 33 AND WE WILL COMPLETE OUR EVAL AND SUBMIT A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    DURING IMPLANT PROCEDURE, THE PHYSICIAN, AFTER HAVING TRIED FOR SOME MINUTES TO ENTER INTO A VESSEL BY OVER THE WIRE TECHNIQUE, KEPT OUT THE GUIDEWIRE AND MANUALLY J-SHAPED THE DISTAL PART OF IT. THE GUIDE WAS THEN REINSERTED IN THE LEAD AND, WITHOUT ANY PARTICULAR FRICTION OR DIFFICULTY IN MANEUVERABILITY, ENTERED INTO A POSTERO-LATERAL VESSEL WHERE LEAD WAS THEN POSITIONED. THE GUIDE WAS THEN REMOVED WITHOUT ANY RESISTANCE BUT A DISTAL PART OF ABOUT 2CM REMAINED IN THE VESSEL. THE PHYSICIAN DECIDED TO IMPLANT THE LEAD ANYWAY IN THAT VESSEL; ELECTRICAL MEASURES WERE IN RANGE IN ALL PACING CONFIGURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COURIER GUIDEWIRE GUIDEWIRE DQX BRIVANT, LTD. DS2G002 90015049

    Patients

    Seq Age Sex Outcome Treatment
    1