BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP

    MDR report key: 12666869 · Received October 20, 2021

    Report

    Report Number
    3011706110-2021-00045
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    September 9, 2021
    Report Date
    October 20, 2021
    Manufacturer
    ATRICURE, INC.
    Product Code
    PZX
    PMA / PMN Number
    K181474
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION AND A DEVICE HISTORY REVIEW WAS UNABLE TO BE COMPLETED AS THE RELEVANT LOT NUMBER FOR THE DEVICE WAS NOT REPORTED OR ABLE TO BE SUBSEQUENTLY ASCERTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021 A PATIENT UNDERWENT AN ON-PUMP OPEN STERNOTOMY LVAD (LEFT VENTRICULAR ASSIST DEVICE) WITH LEFT ATRIAL APPENDAGE MANAGEMENT. WHEN THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE PRO240 CLIP, THE LEFT ATRIAL APPENDAGE WAS INJURED BY THE DISTAL TIP OF THE CLIP. THE SURGEON REMOVED THE PRO240 CLIP AND A SECOND CLIP, AN ACHV40 WAS PLACED WHICH MANAGED THE PERFORATION. THE LVAD WAS COMPLETED AND PATIENT WAS STABLE POST PROCEDURE. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565750 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP PZX ATRICURE, INC. PRO240 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R ACHV40