BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE FIT ULTRA SYSTEM

    MDR report key: 23501263 · Received November 7, 2025

    Report

    Report Number
    2124215-2025-78691
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    00191506007669
    PMA / PMN Number
    K211223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE PREMARKET / 510(K) #: K211223, K231549. DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF MESH DETACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A MID-URETHRAL SLING PROCEDURE USING AN ADVANTAGE FIT ULTRA DEVICE, THE MESH AND SHEATH WERE DISCONNECTED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172388 ADVANTAGE FIT ULTRA SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET OTN BOSTON SCIENTIFIC CORPORATION M0068502160 0036508742 00191506007669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown