BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 6094756 · Received November 10, 2016

    Report

    Report Number
    3003502395-2016-00163
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 11, 2016
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K160454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION, HOWEVER THE DEVICE HISTORY REVIEW WAS UNABLE TO BE COMPLETED AS THE RELEVANT DEVICE LOT/SERIAL NUMBER WAS NOT REPORTED OR ABLE TO BE SUBSEQUENTLY ASCERTAINED. THE COMPLAINT COULD NOT BE CONFIRMED. DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    DURING A CONVERGENT CASE WITH LAA OCCLUSION, THE CLIP FAILED TO CLOSE IN THE BODY. IT WAS REMOVED WITHOUT INTERVENTION. DURING USE OF A SECOND CLIP THE ORANGE TAB CAME LOOSE AND DEPLOYMENT WIRES WOULD NOT RELEASE. THE SURGEON MANIPULATED THE WIRE USING HEAVY SCISSORS AND PLACED THE CLIP. THE PROCEDURE WAS PROLONGED 20 MINUTES. THE PATIENT OUTCOME WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745725 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM FZP ATRICURE, INC. PRO240 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1