BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE FIT ULTRA SYSTEM

    MDR report key: 24030438 · Received January 9, 2026

    Report

    Report Number
    2124215-2026-01717
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    December 11, 2025
    Report Date
    January 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    00191506007669
    PMA / PMN Number
    K211223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PREMARKET / 510(K) #S ARE K211223 & K231549. DEVICE CODE A150205 CAPTURES THE REPORTABLE CODE OF DEVICE DIFFICULT TO ADVANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MID-URETHRAL SLING PROCEDURE USING AN ADVANTAGE FIT ULTRA SYSTEM, THE DEVICE WAS DIFFICULT TO ADVANCE CAUSING THE BLUE SHEATH TO SLIP BACK ON TROCAR. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89175 ADVANTAGE FIT ULTRA SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET OTN BOSTON SCIENTIFIC CORPORATION M0068502160 0037165749 00191506007669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown