BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP GILLINOV-COSGROVE LAA EXLUSION SYSTEM

    MDR report key: 2052943 · Received April 13, 2011

    Report

    Report Number
    3003502395-2011-00005
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K093679
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE NOT RETURNED FOR EVALUATION, ANOTHER (B)(4) FROM A SIMILAR LOT NUMBER WAS EVALUATED AND PERFORMANCE MET SPECIFICATIONS. (B)(4): NO DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    DURING THE INITIAL PROCEDURE ON (B)(6) 2011 AN ATRICLIP GILLINOV-COSGROVE LAA EXCLUSION DEVICE WAS USED. DURING THE CLIP PLACEMENT, THE PHYSICIAN PLACED THE CLIP ON THE LEFT ATRIAL APPENDAGE WITHOUT ISSUE. THE CLIP SUTURES WERE CUT AT THE HANDLE RELEASING THE CLIP. THE PHYSICIAN TRIED TO CUT OFF THE REMNANTS OF THE SUTURES FROM THE CLIP WHILE ON THE HEART. AS THE PHYSICIAN WAS CUTTING THE SUTURES FROM THE CLIP, HE NICKED THE ATRIUM WITH THE SCISSOR TIPS. HE HAD TO EXTEND THE THORACOTOMY TO REPAIR THE ATRIUM. A SINGLE STITCH WAS PLACED AND THE PROCEDURE FINISHED WITH NO FUTHER COMPLICATIONS. THERE WAS NO LONG TERM PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRICLIP GILLINOV-COSGROVE LAA EXLUSION SYSTEM CLIP, IMPLANTABLE FZP ATRICURE, INC. LAA050 28470

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other| R