BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 18039387 · Received October 31, 2023

    Report

    Report Number
    3005099803-2023-05825
    Event Type
    Injury
    Date Received
    October 31, 2023
    Date of Event
    February 24, 2011
    Report Date
    October 31, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729784777
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK E1: THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANT SURGEONS ARE: (B)(6). BLOCK H6: IMDRF PATIENT CODES E211401 AND E0506 CAPTURE THE REPORTABLE EVENTS OF BLADDER PERFORATION AND BLEEDING FROM THE RIGHT TUBE. IMDRF IMPACT CODE F23 CAPTURE THE REPORTABLE EVENT OF RIGHT SALPINGECTOMY DUE TO BLEEDING.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TOTAL VAGINAL HYSTERECTOMY + ANTERIOR REPAIR + (TENSION-FREE VAGINAL TAPE) TVT SLING + CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2011, FOR THE TREATMENT OF UTERINE PROLAPSE, CYSTOCELE, STRESS URINARY INCONTINENCE. FINDINGS INCLUDED UTERINE PROLAPSE TO HALFWAY VAGINA AND CYSTOCELE AT THE HYMENAL RING. UTERUS SIZE 6-11 WEEKS. TUBES AND OVARIES WERE NORMAL. NO LESIONS. CYSTOSCOPY SHOWED NO PROBLEMS, BUT THERE WAS A SMALL PERFORATION ON THE LEFT POSTEROLATERAL WALL AND MINIMAL BLEEDING. INDIGO CARMINE SEEN FROM BOTH URETERAL ORIFICES. DURING THE PROCEDURE, THERE WAS SOME BLEEDING FROM THE RIGHT TUBE, AND WAS DECIDED TO PERFORM A RIGHT SALPINGECTOMY. THE OVARY NOTED TO BE NORMAL AND HEMOSTATIC AFTER THE RIGHT FALLOPIAN TUBE WAS LIGATED. WHILE THE TVT SHEETS WERE IN PLACE, CYSTOSCOPY WAS PERFORMED NOTING NO DAMAGE TO THE BLADDER, NO TVT SHEETS NOTED WITHIN THE BLADDER. HOWEVER, ONE AREA OF THE BLADDER AT THE LATERAL ASPECT NOTED A SMALL PERFORATION, POSSIBLY SECONDARY TO THE CYSTOSCOPE. THE BLEEDING WAS CONTROLLED. ALSO, INDIGO CARMINE GIVEN AND EXCELLENT FLOW FROM BOTH URETERS VISUALIZED WITH THE CYSTOSCOPY. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882229 ADVANTAGE FIT SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068502111 1ML0091603 08714729784777

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention