BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 5980355 · Received September 27, 2016

    Report

    Report Number
    3003502395-2016-00120
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    August 31, 2016
    Report Date
    August 31, 2016
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K122276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT NOT YET EVALUATED. WHEN ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION AND VISUALLY AND FUNCTIONALLY TESTED PURSUANT TO QRF-0271.E. THE COMPLAINT COULD NOT BE CONFIRMED, AS THE CLIP HAD BEEN DEPLOYED. THERE WERE NO VISIBLE DEFECTS FOUND IN THE CABLE OR CABLE PATH. THERE WERE INDENTATIONS ON THE PROXIMAL END OF THE HANDLE HALVES WHERE THE TAB EXITS THE HANDLE, INDICATING THAT THE TAB HAD BEEN PULLED IN AN UPWARD DIRECTION INSTEAD OF STRAIGHT OUT, WHICH WOULD HAVE INCREASED THE RESISTANCE FELT BY THE SURGEON. FOLLOW-UP WITH THE REP REVEALED THAT THE UNIVERSAL BREAKAGE DID NOT TAKE PLACE DURING THE CASE, BUT LIKELY ON THE RETURN SHIPMENT TO ATRICURE.

    Description of Event or Problem · 1

    DURING A STAND ALONE VATS MAZE PROCEDURE, THE ORANGE "RIP CORD" WOULD NOT COME OUT TO INITIATE DEPLOYMENT. THE CASE WAS MOMENTARILY DELAYED WHILE THE DOCTOR USED A GRASPER TO YANK THE RIP CORD OUT TO DEPLOY CLIP. THE PATIENT OUTCOME WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630405 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP FZP ATRICURE, INC. PRO140 65934

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR