BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 18148553 · Received November 16, 2023

    Report

    Report Number
    2124215-2023-62730
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    October 17, 2023
    Report Date
    December 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729772880
    PMA / PMN Number
    K020110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKS B5 AND H6 HAVE BEEN UPDATED BASED ON THE NEW INFORMATION RECEIVED ON NOVEMBER 17, 2023. BLOCK H6: IMDRF DEVICE CODE A040609 CAPTURES THE REPORTABLE EVENT OF TWISTED MESH.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A040609 CAPTURES THE REPORTABLE EVENT OF TWISTED MESH.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT SYSTEM WAS USED DURING A MID-URETHRAL SLING PLACEMENT FOR THE TREATMENT OF A STRESS URINARY INCONTINENCE (SUI) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE MESH TWISTED WITHIN THE SHEATH. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 17, 2023: THE PROBLEM WAS NOTICED DURING THE UNPACKING OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT SYSTEM WAS USED DURING A MID-URETHRAL SLING PLACEMENT FOR THE TREATMENT OF A STRESS URINARY INCONTINENCE (SUI) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE MESH TWISTED WITHIN THE SHEATH. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192904 ADVANTAGE FIT SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068502110 0032036726 08714729772880

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown