BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 3954762 · Received July 18, 2014

    Report

    Report Number
    3008788191-2014-00003
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 18, 2014
    Manufacturer
    LAAX INC.
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CASE WAS PERFORMED OFF-PUMP. THE SURGEON ((B)(6) ADDRESSED THE LAA TOWARDS THE END OF THE CASE. UPON APPLYING THE TIGERPAW TO THE LEFT ATRIAL APPENDAGE, AND REMOVING THE DEVICE, A WHOLE IN THE LEFT ATRIUM WAS IMMEDIATELY DETECTED. THE SURGEON COULD NOT REPAIR THE HOLE. THEREFORE, HE USED HIS FINGER TO PLUG THE HOLE AND ORDERED A "CRASH-ON". THE PATIENT WAS THEN CANNULATED AND PUT ON PUMP. THE APPENDAGE WAS THEN RESECTED AND THE HOLE WAS CLOSED USING TRADITIONAL METHODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422535 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC. TP15AJ07

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention OPEN CARDIAC SURGERY PROCEDURE