BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 14394557 · Received May 13, 2022

    Report

    Report Number
    3011706110-2022-00017
    Event Type
    Injury
    Date Received
    May 13, 2022
    Date of Event
    April 13, 2022
    Report Date
    May 13, 2022
    Manufacturer
    ATRICURE, INC.
    Product Code
    PZX
    UDI-DI
    30840143900185
    PMA / PMN Number
    K210293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CASE (B)(6) THE PRO240 DEVICE WAS NOT RETURNED FOR EVALUATION, BUT A DEVICE HISTORY REVIEW WAS OBTAINED FOR LOT NUMBER MF1152A. THERE IS NOTHING IN THE DEVICE HISTORY RECORD THAT WOULD INDICATE THAT THE DEVICES WERE RELEASED WITH ANY NON-CONFORMANCES THAT WOULD CONTRIBUTE TO THE COMPLAINT.

    Description of Event or Problem · 0

    ON (B)(6) 2022 A PATIENT UNDERWENT A ROBOTIC CRYO MAZE WITH CONCOMITANT LEFT ATRIAL APPENDAGE MANAGEMENT. PRIOR TO CLIP PLACEMENT, THE PHYSICIAN NOTICED A THROMBUS IN THE LAA, BUT PROCEEDED WITH THE PROCEDURE. THE CLIP WAS DEPLOYED AND DURING DEPLOYMENT THE THROMBUS MIGRATED INTO THE LEFT ATRIUM AND THEN OUT OF THE ATRIUM INTO THE BODY. POST-PROCEDURE, THE CLOT EMBOLIZED TO LEFT KIDNEY AND WAS REMOVED IN A FOLLOW-UP PROCEDURE. THE PATIENT IS DOING WELL AND THERE WERE NO LONG-TERM COMPLICATIONS. THIS WAS A PROCEDURAL COMPLICATION WITH NO REPORTED DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131835 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP PZX ATRICURE, INC. PRO240 MF1152A 30840143900185

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R