BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 3735686 · Received April 1, 2014

    Report

    Report Number
    3008788191-2014-00001
    Event Type
    Injury
    Date Received
    April 1, 2014
    Date of Event
    October 18, 2013
    Report Date
    April 1, 2014
    Manufacturer
    LAAX, INC.
    Product Code
    GDW
    PMA / PMN Number
    K111064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, CONTACTED (B)(4), THE MAQUET TERRITORY MANAGER WHO REPORTED THE INCIDENT, AND DISCUSSED THE INCIDENT BY PHONE. THE SURGEON INVOLVED, (B)(6) MD, WAS TRAINED BY TERUMO, THE PREVIOUS DISTRIBUTOR FOR LAAX, INC. IN THE USA. UPON LEARNING OF THIS INCIDENT, (B)(4) BOTH TALKED WITH THE ATTENDED SEVERAL OF DR. (B)(4)'S LAA OCCLUSION PROCEDURES WITH THE TIGERPAW SYSTEM II. THE SURGEON WAS ACTUATING THE 1ST TRIGGER TO THE FIRST "CLICK" AND THEN ACTUATING THE 2ND TRIGGER RELEASING THE FASTENER. THIS SEQUENCE IS NOT ACCORDING TO THE IFU. (B)(4) INFORMED THE SURGEON OF THE CORRECT PROCEDURE RE THE 1ST TRIGGER AND THE SURGEON HAS NOT HAD ANY FURTHER INCIDENT WITH OUR DEVICE. THIS WAS CLEARLY A USER ERROR, WHICH SUBSEQUENTLY HAS BEEN CORRECTED BY THE MAQUET SALES REPRESENTATIVE.

    Description of Event or Problem · 1

    TIGERPAW WAS DEPLOYED - SURGERY COMPLETED - PATIENT WAS IN ICU BLOOD PRESSURE DROPPED - TOOK PATIENT BACK TO OPERATING ROOM - RE-OPENED THE CHEST AND FOUND CLIP HAD FALLEN OFF AND PATIENT WAS BLEEDING FORM THE LEFT ATRIAL APPENDAGE. CLOSED W/FELT AND SEWED THE APPENDAGE CLOSED. ATTENDING PHYSICIAN: DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195247 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE GDW LAAX, INC. TP15AJ07 0666M

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention OPEN CARDIAC SURGICAL PROCEDURE