BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP

    MDR report key: 11723831 · Received April 26, 2021

    Report

    Report Number
    3011706110-2021-00018
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    April 1, 2021
    Report Date
    April 26, 2021
    Manufacturer
    ATRICURE, INC.
    Product Code
    PZX
    PMA / PMN Number
    K191413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE PROV45 DEVICE WAS NOT RETURNED FOR EVALUATION, BUT A DEVICE HISTORY REVIEW WAS OBTAINED FOR LOT NUMBER 94362. 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 · 1

    IT WAS REPORTED THAT ON (B)(6) 2021 A (B)(6) YEAR-OLD MALE PATIENT UNDERWENT AN OFF-PUMP CONVERGENT / LEFT ATRIAL APPENDAGE MANAGEMENT PROCEDURE (LAAM). THE SURGEON STARTED PLACEMENT OF A CLIP ON THE LEFT ATRIAL APPENDAGE AND NICKED THE APPENDAGE. THE SURGEON ATTEMPTED TO USE AN ATRICLIP PROV45 TO MANAGE THE BLEED, BUT DURING PLACEMENT THE APPENDAGE WAS NICKED AGAIN. THE PHYSICIAN CONVERTED THE PROCEDURE TO AN OPEN STERNOTOMY TO MANAGE THE BLEED. AT THE CONCLUSION OF THE PROCEDURE, PATIENT WAS OFF-PUMP AND STABLE. 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
    622781 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED PRO-V CLIP PZX ATRICURE, INC. PRO V45 94362

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R PRO240 - IMPLANTED/EXPLANTED, EPI-SENSE