BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 7138132 · Received December 21, 2017

    Report

    Report Number
    3011706110-2017-00108
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 28, 2017
    Report Date
    December 21, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K160454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED IN THE STATE BASED ON COMPLAINT DESCRIPTION, THE PRO240 CLIP WAS DEPLOYED ON THE LAA. THE COMPLAINT COULD NOT BE CONFIRMED. BASED ON DESCRIPTION, AN INVESTIGATION HAS BEEN OPENED TO ADDRESS COMPLAINTS OF THIS NATURE AND A CORRECTION FOR THIS WILL BE IMPLEMENTED TO PREVENT THIS FAILURE MODE.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A FEMALE PATIENT RECEIVED AN OFF-PUMP, TOTALLY THORACOSCOPIC MAZE PROCEDURE WITH LAA MANAGEMENT USING AN ATRICLIP PRO240. THE PATIENT WAS HEPARINIZED FOR THE PROCEDURE, WITH AN ACT MEASURED AT OVER 300 SECONDS. DURING THE LAA MANAGEMENT PORTION OF THE PROCEDURE, THE ATRICLIP PRO240 DID NOT DEPLOY FULLY. IT WAS REPORTED THAT THE CLIP WAS DEPLOYED, BUT THERE WERE A FEW SUTURES STUCK FROM THE CLIP TO THE APPLICATOR. THE SURGEON PROCEEDED TO CUT THOSE SUTURES TO REMOVE THE APPLICATOR. THE CLIP STAYED IN PLACE AND NO FURTHER COMPLICATION WAS REPORTED. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918672 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP PRO2 GILLINOV-COSGROVE LAA EXCLUSION SYSTEM 40 FZP ATRICURE, INC. PRO240 69630

    Patients

    Seq Age Sex Outcome Treatment
    1