BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4391809 · Received November 14, 2014

    Report

    Report Number
    3008788191-2014-00015
    Event Type
    Injury
    Date Received
    November 14, 2014
    Report Date
    November 13, 2014
    Manufacturer
    LAAX INC
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER THE DEVICE WAS CLIPPED TO THE HEART AND THE PATIENT TAKEN OFF BYPASS, THE SURGEON DR (B)(6) NOTICED MORE BLEEDING THAN NORMAL ON THE BACK SIDE OF THE CLIP. THE PATIENT WAS PUT BACK ON BYPASS, AND THE SURGEON DECOMPRESSED THE HEART. HE THEN USED BIO GLUE ON THE CLIP. THE CLIP WAS LEFT IN PLACE, THE PATIENT WAS TAKEN OFF BYPASS AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739275 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX INC TP15AJ07 0853M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention