BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE FIT SYSTEM

    MDR report key: 1950721 · Received January 6, 2011

    Report

    Report Number
    3005099803-2011-00011
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Product Problem
    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 MID-URETHRAL SLING WAS USED DURING A SLING PLACEMENT PROCEDURE. THE PATIENT WAS REPORTED TO BE OVER (B)(6).ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DILATOR OF THE MESH ASSEMBLY WAS PLACED ON THE NEEDLE OF THE DELIVERY DEVICE. AS THE DELIVERY DEVICE WAS PASSED THROUGH THE PATIENT, THE DILATOR TUBE BUNCHED AND COULD NOT BE PULLED THROUGH THE TISSUE. THE ENTIRE MESH ASSEMBLY WAS REMOVED FROM THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER ADVANTAGE FIT TRANSVAGINAL MID-URETHRAL SLING. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE FIT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068502110 1ML0091403

    Patients

    Seq Age Sex Outcome Treatment
    1