BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 6024519 · Received October 12, 2016

    Report

    Report Number
    3003502395-2016-00128
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 13, 2016
    Manufacturer
    ATRICURE, INC.
    Product Code
    FZP
    PMA / PMN Number
    K160454
    Removal / Correction Number
    3011706110-09/22/2016-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NUMBER (B)(4). IT WAS FOUND THAT THE OPENING CABLE HAD BECOME LODGED BETWEEN THE PULLEY AND THE TOGGLE, PREVENTING THE DEVICE FROM CLOSING. THE COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE, PVI, THE DEVICE WOULD NOT CLOSE. THE DEVICE WAS TESTED OUTSIDE OF THE BODY FOUR TIMES AND FAILED ONCE OUT OF THE FOUR. THE SURGEON DECIDED TO PROCEED USING THE CLIP. WHILE PLACING THE CLIP, IT FAILED TO CLOSE AGAIN. THE SURGEON HAD TO EXTEND THE INCISION TO REMOVE THE CLIP AND USED THE SAME INCISION TO INTRODUCE ANOTHER CLIP. THE CASE WAS DELAYED FOR TEN MINUTES AND THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672393 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM FZP ATRICURE, INC. PRO245 66515

    Patients

    Seq Age Sex Outcome Treatment
    1