BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COURIER GUIDEWIRE

    MDR report key: 2180816 · Received April 28, 2011

    Report

    Report Number
    3006010712-2011-00033
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BRIVANT, LTD.
    Product Code
    DQX
    PMA / PMN Number
    K073082
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL.

    Description of Event or Problem · 1

    COMPLAINT REPORT WAS RECEIVED WITH THE FOLLOWING TEXT: RIGHT VENTRICLE LEAD AND ATRIAL LEAD WERE IMPLANTED WITHOUT COMPLICATIONS. LEFT VENTRICLE LEAD IMPLANT WAS DIFFICULT DUE TO PRESENCE OF VIEUSSENS' VALVE IN CORONARY SINUS. THE VALVE WAS OVERCOME BY MEANS OF A MEDIUM COURIER GUIDEWIRE. THE QUARTET LEAD AND THE CPS AIM WERE GENTLY PUSHED OVER THE GUIDEWIRE BEYOND THE VALVE. A LATERAL VEIN WAS THEN SUBSELECTED WITH THE GUIDEWIRE, AND THE LEAD WAS PUSHED OVER THE GUIDE TO THE TARGET POSITION. THE GUIDEWIRE WAS THEN REMOVED WITHOUT ANY RESISTANCE BUT A DISTAL PART OF ABOUT 2 CM REMAINED IN THE VESSEL. THE GUIDEWIRE STUMP SEEMED TO BE FIXED ALONGSIDE THE DISTAL PART OF THE LEAD. THE PHYSICIAN DECIDED TO LEAVE THE LEAD AND THE GUIDE STUMP IN THE VESSEL. CPS AIM AND DIRECT WERE SLITTED WITHOUT PROBLEMS. AT THE END OF THE PROCEDURE ALL THE ELECTRICAL MEASURES WERE IN RANGE IN ALL PACING CONFIGURATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COURIER GUIDEWIRE GUIDEWIRE DQX BRIVANT, LTD. DS2G002 90015050

    Patients

    Seq Age Sex Outcome Treatment
    1