BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATCHMAN FLX? PRO

    MDR report key: 22061456 · Received May 21, 2025

    Report

    Report Number
    2124215-2025-32375
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    May 14, 2025
    Report Date
    August 22, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004606
    PMA / PMN Number
    P130013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A. PATIENT INFORMATION - ADDED PATIENT INFORMATION. MEDIA EVALUATED BY BSC QUALITY ENGINEER: MEDIA FROM THE CLINICAL PROCEDURE WAS PROVIDED AND REVIEWED BY MEMBERS OF THE BSC TRAINING TEAM, MEDICAL SAFETY, PHYSICIAN TRAINING, AND CLINICAL SPECIALISTS. THE MEDIA REVIEW REPORT CONCLUDED: IMAGING IS CONSISTENT WITH FABRIC FLUTTER BUT DOES NOT DEPICT DAMAGE TO THE FABRIC. MEDIA REVIEW COULD NOT CONFIRM FABRIC DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE FABRIC CAP WAS DAMAGED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 27MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE. THE WDS WAS PREPARED, ADVANCED AND DEPLOYED IN THE LAA. UPON RELEASE OF THE CLOSURE DEVICE, IT WAS NOTED THAT THE FABRIC CAP APPEARED TO HAVE A FLAPPING FABRIC HAT AROUND THE THREADED INSERT. NO INTERVENTION WAS PERFORMED. THE DEVICE WAS LEFT IN PLACE, AND THE PHYSICIAN WILL CHECK IT AT THE 45 DAY FOLLOW UP.

    Description of Event or Problem · 0

    IT WAS REPORTED THE FABRIC CAP WAS DAMAGED. A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 27MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS SELECTED FOR USE. THE WDS WAS PREPARED, ADVANCED AND DEPLOYED IN THE LAA. UPON RELEASE OF THE CLOSURE DEVICE, IT WAS NOTED THAT THE FABRIC CAP APPEARED TO HAVE A FLAPPING FABRIC HAT AROUND THE THREADED INSERT. NO INTERVENTION WAS PERFORMED. THE DEVICE WAS LEFT IN PLACE, AND THE PHYSICIAN WILL CHECK IT AT THE 45 DAY FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57735 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60270 0035960608 00191506004606

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male