BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 6087806 · Received November 8, 2016

    Report

    Report Number
    3003502395-2016-00153
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 11, 2016
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K160454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED AT THE FACILITY AND NOT RETURNED TO THE MANUFACTURER. A DEVICE HISTORY REVIEW WAS PERFORMED PURSUANT TO ATRICURE PROCESS AND PROCEDURES WHICH REVEALED NO HIGH SCRAP RATES ABD NO NON-CONFORMANCES FOR THIS LOT. THERE WAS ONE RE-WORK NOTED HOWEVER NO DEVICES WERE SCRAPPED AND ALL DEVICES PASSED 100% INSPECTION. A DEVIATION WAS ISSUED HOWEVER UNRELATED TO THE REPORTED ISSUE. THERE IS NOTHING IN THE DEVICE HISTORY REVIEW TO INDICATE DEVICES RELEASED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. DEVICE DISCARDED AT FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT-SIDED MITRAL MAZE, THE CLIP WAS OPENED BUT NOT USED. DURING TESTING, PRIOR TO INSERTING THE DEVICE INTO THE PATIENT, THE CLIP WAS OBSERVED TO NOT CLOSE. ANOTHER DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER CONSEQUENCE. THERE WAS NO DELAY OF CASE OR AFFECT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737203 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM FZP ATRICURE, INC. PRO245 67210R

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR