BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 20902082 · Received December 11, 2024

    Report

    Report Number
    2124215-2024-76245
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 12, 2024
    Report Date
    December 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729772880
    PMA / PMN Number
    K020110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A150205 CAPTURES THE REPORTABLE EVENT OF DIFFICULTY TO ADVANCE CAUSING THE PHYSICIAN TO EXERT EXTRA EFFORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A STRESS URINARY INCONTINENCE PROCEDURE USING AN ADVANTAGE FIT SYSTEM DEVICE, THE DILATOR DEFORMED WHILE IT WAS BEING ADVANCED TO THE PATIENT. THE PHYSICIAN EXERTED EXTRA FORCE WHILE ADVANCING THE DEVICE. 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
    2569244 ADVANTAGE FIT SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068502110 33312793 08714729772880

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown