BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA

    MDR report key: 6206737 · Received December 27, 2016

    Report

    Report Number
    3003502395-2016-00175
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 28, 2016
    Manufacturer
    ATRICURE INC.
    Product Code
    FZP
    PMA / PMN Number
    K160454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND SENT TO ATRICURE ENGINEERING FOR ANALYSIS. UPON INSPECTION, IT WAS FOUND THAT THE OPENING CABLE WAS JAMMED BETWEEN THE TOGGLE AND THE PULLEY IN THE END EFFECTOR, WHICH INTERFERED WITH THE NORMAL OPENING AND CLOSING ACTIONS OF THE DEVICE. THE COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    A CLIP FAILED TO DEPLOY. THE ORANGE TAB DISCONNECTED FROM THE DEVICE, FINALLY IT DEPLOYED BUT FAILED TO CLOSE AND IT WASN'T POSSIBLE TO REMOVE THROUGH THE PORT. THE CLIP WAS TESTED PRIOR TO USING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855473 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA ATRICLIP LAA EXCLUSION SYSTEM FZP ATRICURE INC. PRO240 68634

    Patients

    Seq Age Sex Outcome Treatment
    1