BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 7017771 · Received November 10, 2017

    Report

    Report Number
    3011706110-2017-00097
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    October 5, 2017
    Report Date
    November 9, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K160454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED FOR EVALUATION. AN INVESTIGATION IS IN-PROGRESS FOR APPROPRIATE CORRECTIVE ACTIONS. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2017, A (B)(6) MALE PATIENT WITH A HISTORY OF ATRIAL FIBRILLATION RECEIVED AN OFF-PUMP SURGICAL LAA CLOSURE USING AN ATRICLIP PRO245. THE PATIENT WAS HEPARINIZED FOR THE PROCEDURE. DURING THE PROCEDURE, THE RELEASE SYSTEM WAS BROKEN AND THE SURGEON HAD TO PULL THE WIRES INSTEAD OF USING THE ORANGE DEPLOYMENT TAB ON THE DEVICE TO RELEASE THE CLIP. THE CLIP WAS PLACED WITH THE DEVICE, THERE WAS NO DELAY IN THE CASE AND THE PROCEDURE WAS DONE PROPERLY. THERE WAS NO REPORTED IMPACT ON PATIENT CARE OR OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801711 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP PRO2 GILLINOV-COSGROVE LAA EXCLUSION SYSTEM 45 FZP ATRICURE, INC. PRO245 69386

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR