BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIGERPAW SYSTEM II

    MDR report key: 4972797 · Received August 3, 2015

    Report

    Report Number
    3008788191-2015-00071
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    May 28, 2014
    Report Date
    May 30, 2014
    Manufacturer
    LAAX INC
    Product Code
    CDW
    Removal / Correction Number
    Z-1461-2015 Z-1462-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH HAZARD EVAL (HHE) WAS COMPLETED.

    Description of Event or Problem · 1

    DISTAL PINS OF THE TIGERPAW SYSTEM II DEVICE WERE NOT ENGAGED. THESE PINS WERE NOT ON TISSUE. A LOOPED SUTURE WAS USED TO COMPLETE PROCEDURE TO SECURE CLOSURE OF LEFT ATRIUM APPENDAGE. NO KNOWN BLOOD LOST OR INJURY REFERRED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505049 TIGERPAW SYSTEM II STAPLE, IMPLANTABLE CDW LAAX INC TP15AJ07 0853M

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR