BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE

    MDR report key: 23768863 · Received December 10, 2025

    Report

    Report Number
    MW5180251
    Event Type
    Death
    Date Received
    December 10, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 5, 2025
    Manufacturer
    ATRICURE, INC.
    Product Code
    PZX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    EQUIPMENT MALFUNCTION DURING USE ON A PATIENT. ATRICURE PROV50 ATRICLIP WOULD NOT FIRE WHEN ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2885655 LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE PZX ATRICURE, INC. PROV50 157154

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death