BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4390414 · Received December 19, 2014

    Report

    Report Number
    3008788191-2014-00042
    Event Type
    Injury
    Date Received
    December 19, 2014
    Report Date
    December 16, 2014
    Manufacturer
    LAAX, INC.
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TIGERPAW SYSTEM II DEVICE DIDN'T DEPLOY ALL THE WAY TO THE END. LEFT ATRIAL APPENDAGE WAS OVERSEEN BY ANOTHER DEVICE. BLEEDING AND PUMP TIME WAS INCREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837437 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX, INC. TP15AJ09 1404M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention