BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX? PRO

    MDR report key: 22922156 · Received August 29, 2025

    Report

    Report Number
    2124215-2025-60736
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    July 15, 2025
    Report Date
    August 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004620
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORTED VIA CLINICAL STUDY IT WAS REPORTED THAT A DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 35MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2025. THE PATIENT WAS DISCHARGED. DURING A CORE LAB 45-DAY COMPUTED TOMOGRAPHY (CT) SCAN REVIEW, A 6.39 MM PERI DEVICE LEAK WAS NOTED. NO CORRECTIVE ACTIONS OR DIAGNOSTIC TESTS ARE ASSOCIATED WITH THIS FINDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2838114 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60350 0035905005 00191506004620

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Other