BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 18007863 · Received October 25, 2023

    Report

    Report Number
    3005099803-2023-05772
    Event Type
    Injury
    Date Received
    October 25, 2023
    Date of Event
    February 8, 2019
    Report Date
    October 25, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729470274
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT EVENT ONSET DATE IS UNKNOWN. THE PROVIDED EVENT DATE OF (B)(6) 2019, WAS CHOSEN AS THE BEST ESTIMATE BASED ON THE DATE OF THE REVISION SURGERY. BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANTING PHYSICIAN IS: DR. (B)(6). BLOCK H6: IMDRF PATIENT CODE E211401 CAPTURES THE REPORTABLE EVENT OF BLADDER PERFORATION. IMDRF PATIENT CODE E0505 CAPTURES THE REPORTABLE EVENT OF MINIMAL AMOUNT OF CLOT. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF REMOVAL OF TENSION-FREE VAGINAL TAPE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE SYSTEM DEVICE WAS IMPLANTED DURING A TENSION-FREE VAGINAL TAPE PLACEMENT WITH CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019, FOR THE TREATMENT OF STRESS URINARY INCONTINENCE. THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2019, THE PATIENT HAD A CYSTOSCOPY AND REMOVAL OF TENSION-FREE VAGINAL TAPE PROCEDURE DUE TO A BLADDER PERFORATION. DURING THE PROCEDURE, THE CYSTOSCOPE WAS PERFORMED AND A SMALL AREA WHERE TAPE WAS VISUALIZED ON THE RIGHT SIDE OF THE BLADDER JUST INSIDE THE BLADDER NECK. THER WAS A MINIMAL AMOUNT OF CLOT PRESENT. THE VAGINAL TAPE WAS VISUALIZED WITHOUT DIFFICULTY AND WAS REMOVED EASILY. THE PATIENT WAS AWAKENED, EXTUBATED, AND TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434192 ADVANTAGE SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068502000 0022180865 08714729470274

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention