BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4397811 · Received November 26, 2014

    Report

    Report Number
    3008788191-2014-00035
    Event Type
    Injury
    Date Received
    November 26, 2014
    Date of Event
    May 30, 2014
    Report Date
    November 26, 2014
    Manufacturer
    LAAX, INC.
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEAKING WAS NOTED AFTER TIGERPAW DEVICE WAS USED ON THE LEFT ATRIAL APPENDAGE (CENTER 2 FASTENER'S CONNECTORS HAD COME UNDONE. THE DOCTOR USED A 2ND TIGERPAW DEVICE BUT STILL NOT SURE ABOUT LEAKING. THE PT WAS RETURNED ON BYPASS. THE DEFECT WAS SUTURED. THE PT RECEIVED A TRANSFUSION (NOT INDICATIVE OF THE TIGERPAW DEVICE FAILURE). THE AMOUNT OF BLOOD LOSS WAS 30 CC. PT CONDITION WAS DESCRIBED AS STABLE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769759 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX, INC. TP15AJ07 1041M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention