BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE FIT BLUE SYSTEM

    MDR report key: 21678506 · Received March 24, 2025

    Report

    Report Number
    2124215-2025-17692
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    March 3, 2025
    Report Date
    May 6, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729961925
    PMA / PMN Number
    K020110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: DEVICE CODE A150205 CAPTURES THE REPORTABLE CODE OF DEVICE DIFFICULT TO ADVANCE. H11: CORRECTION TO FIELDS B5: DESCRIBE EVENT OR PROBLEM AND H6: DEVICE CODES.

    Additional Manufacturer Narrative · 0

    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 BLUE SYSTEM, THE DEVICE WAS DIFFICULT TO ADVANCE CAUSING THE TROCAR TO SLIP BACK. THE DILATOR ARM DETACHED FROM THE TROCAR, AND THE NEEDLE TIP PIERCED THE PLASTIC DILATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A MID-URETHRAL SLING PROCEDURE USING AN ADVANTAGE FIT BLUE SYSTEM, THE DEVICE WAS DIFFICULT TO ADVANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458771 ADVANTAGE FIT BLUE SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068502120 0035590966 08714729961925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown