BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 583274 · Received March 8, 2005

    Report

    Report Number
    583274
    Event Type
    Other
    Date Received
    March 8, 2005
    Date of Event
    March 7, 2005
    Report Date
    March 8, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS ATTEMPTING TO PLACE A TRANSVAGINAL MID URETHRAL SLING SYSTEM INTO A PATIENT WHEN A PIECE OF THE SLING BROKE OFF AND WAS LEFT IN THE PATIENT. A C-ARM FLUORO (FLUOROSCOPY) UNIT HAD TO BE USED TO LOCATE THE BROKEN PART. IT WAS THEN REMOVED FROM THE PATIENT. THE PATIENT WAS NOT HARMED BY THIS DEFECT, BUT THE SURGERY TIME WAS EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC MID URETHRAL SLING SYSTEM FTL BOSTON SCIENTIFIC OBTRYX HALO OML4120102

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR