BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 6464686 · Received April 6, 2017

    Report

    Report Number
    3011706110-2017-00036
    Event Type
    Malfunction
    Date Received
    April 6, 2017
    Date of Event
    February 21, 2017
    Report Date
    February 21, 2017
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K122276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE DEVICE WAS RETURNED FOR EVALUATION AND VISUALLY AND FUNCTIONALLY TESTED PURSUANT TO QRF-0271.E. THE DEVICE WAS RETURNED FROM THE FACILITY WITH A COMPLAINT THAT THE DEVICE WAS DEFECTIVE AND THE END WOULDN'T CLOSE. UPON EVALUATION, IT WAS FOUND THAT THE DEPLOYMENT CABLES COULD NOT BE REMOVED COMPLETELY. THE CABLES ARE PARTIALLY PULLED OUT AND THE ORANGE TAB HAS BECOME DISLODGED. SLIGHT FRAYING OF THE CABLE IS VISIBLE WHERE IT RUNS THROUGH THE UNIVERSAL JOINT. FURTHER INSPECTION OF THIS AREA REVEALED THAT THE FRAYED DEPLOYMENT CABLE HAD TWISTED OVER THE DEPLOYMENT CABLE DURING ASSEMBLY, CAUSING IT TO SLICK IN THAT LOCATION. IT APPEARS THAT THIS DEFECT WAS OVERLOOKED DURING NORMAL FINAL ASSEMBLY INSPECTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END OF THE PRO140 WOULD NOT CLOSE DIRECTLY OUT OF THE PACKAGE. A SECOND CLIP WAS USED WITH SUCCESS. THERE WAS ONLY A DELAY FOR ONE MINUTE TO THE CASE AND NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246086 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP FZP ATRICURE, INC. PRO140 68689

    Patients

    Seq Age Sex Outcome Treatment
    1