BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 6118994 · Received November 21, 2016

    Report

    Report Number
    3003502395-2016-00166
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 3, 2016
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K160454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO ATRICURE FOR EVALUATION AND VISUALLY AND FUNCTIONALLY TESTED PURSUANT TO QRF-0387.A. THE DEVICE MET ALL SPECIFICATIONS. THE DEVICE OPENS AND CLOSES AS INTENDED AND NO CABLE WEDGING WAS OBSERVED. IT WAS ABLE TO BE REMOVED FROM THE TROCAR AS EXPECTED. THE DEVICE WAS RETURNED WITH THE HANDLE IN THE LOCKED POSITION, IMPLYING THE USER HAD NOT PRESSED THE ORANGE TRIGGER IN ORDER TO RELEASE THE JAWS AND ALLOW THEM TO COLLAPSE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT NOT YET EVALUATED. WHEN ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING STAND ALONE LEFT ATRIAL APPENDAGE CLIPPING, AFTER THE CLIP WAS DEPLOYED, THE DEVICE WOULDN'T CLOSE BACK IN ORDER TO PULL IT OUT OF THE CHEST. THE PATIENT'S INCISION HAD TO GET LARGER TO ACCOMMODATE REMOVING THE DEVICE WITH THE JAWS OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767313 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM FZP ATRICURE, INC. PRO235 69016

    Patients

    Seq Age Sex Outcome Treatment
    1