BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 2163043 · Received July 15, 2011

    Report

    Report Number
    3005099803-2011-02370
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT TRANSVAGINAL SLING SYSTEM WAS USED DURING A MID-URETHRAL SLING PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN PLACED THE SLING ON THE PATIENT'S LEFT SIDE AND THEN THE CONTRALATERAL SIDE. A CYSTOSCOPY REVEALED THAT THE BLUE DILATOR TUBES HAD PERFORATED THE PATIENT'S BLADDER ON BOTH SIDES. THE SLING WAS THEN COMPLETELY REMOVED FROM THE PATIENT. THE PATIENT WAS PRESCRIBED CIPRO POST PROCEDURE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE WITH NO OTHER COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE." A FOLEY CATHETER WAS PLACED WITHIN THE PATIENT'S BLADDER, BUT NO MEDICAL INTERVENTION WAS PERFORMED OR PLANNED. IT WAS REPORTED THAT THE PATIENT IS NO LONGER CATHETERIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE FIT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068502110 1ML1010302

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other