BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4391863 · Received November 18, 2014

    Report

    Report Number
    3008788191-2014-00018
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    November 12, 2013
    Report Date
    November 17, 2014
    Manufacturer
    LAAX INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EDELIVERY TOOL RECEIVED WAS VERY CLEAN. AFTER RELOADING THE DELIVERY TOOL AND FIRING, THE DEVICE FUNCTIONED AS PER THE IFU. THIS INDICATES THAT THERE WAS NO PROBLEM WITH THE DELIVERY TOOL.

    Description of Event or Problem · 1

    PROCEDURE: CAPG WITH LAA OCCLUSION. INCIDENT: THE SURGEON APPLIED THE TIGERPAW SYSTEM II ACROSS THE LEFT ATRIAL APPENDAGE. HE REPOSITIONED ONCE AND WAS ABOUT 6 MM AWAY FROM THE LEFT ATRIAL. HE FIRED THE INSTRUMENT AND IT PLACED THE FASTENER AS INDICATED. UPON OBSERVING THE FASTENER, HE NOTICED A TEAR IN THE APPENDAGE PROXIMAL TO THE FASTENER AND ON THE POSTERIOR SIDE OF APPENDAGE. THE BLEEDING COULD NOT BE CONTROLLED, AND THE PATIENT WAS PLACED FULLY ON BYPASS AT THIS POINT SO THAT HE COULD REPAIR THE TEAR. BIOGLUE AND BARD FELT WERE APPLIED AND HE CLOSED THE TEAR USING A STITCH THROUGH THESE MATERIALS FROM THE INSIDE AND INTO THE SILICONE MATERIAL OF THE FASTENER. A LEAK WAS DETECTED UPON WEANING THE PATIENT OFF OF BYPASS. THE PATIENT LOST AN UNKNOWN AMOUNT OF BLOOD. THE SURGEON SPENT ABOUT 45 MINUTES REPAIRING THE TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747260 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ07 0932M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention