BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 6216016 · Received December 30, 2016

    Report

    Report Number
    3003502395-2016-00180
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 2, 2016
    Manufacturer
    ATRICURE INC.
    Product Code
    FZP
    PMA / PMN Number
    K122276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ARTICULATION CABLE HAD SLIPPED, INTRODUCING SLACK TO THE SYSTEM AND PREVENTING THE LOCKING MECHANISM FROM FUNCTIONING PROPERLY, THE COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    DURING A STAND ALONE PROCEDURE, THE SURGEON TRIED PLACING THE CLIP, USING THE ARTICULATION LOCK TO FIX THE HEAD, THE LOCKING MECHANISM WASN'T WORKING. THEY OPENED ANOTHER PRO150 AND COMPLETED THE PROCEDURE. THERE WAS A DELAY IN PROCEDURE BUT, PATIENT OUTCOME AND CARE WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865654 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM FZP ATRICURE INC. PRO150 58726

    Patients

    Seq Age Sex Outcome Treatment
    1