BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX MID-URETHRAL SLING SYSTEM

    MDR report key: 914791 · Received September 18, 2007

    Report

    Report Number
    6000043-2007-00111
    Event Type
    Injury
    Date Received
    September 18, 2007
    Report Date
    August 22, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. THREE POSSIBLE LOTS HAVE BEEN IDENTIFIED FOR THE DEVICE: 0ML61215-02, 0ML70507-01 AND 0ML70515-01. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THESE LOTS; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS WAS CONDUCTED; NO ADDITIONAL COMPLAINTS HAVE BEEN RECORDED FOR THESE LOTS. THE JULY 2007 15-MONTH MID URETERAL SLING COMPLAINT, TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TREND WAS NOTED AND NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT. OUR DFU (DIRECTIONS FOR USE) INDICATES THAT VAGINAL EXTRUSION AND EROSION THROUGH SURROUNDING TISSUE IS A POTENTIAL COMPLICATION OF SUB-URETERAL SLING PLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A TRANSAOBTURATOR SLING PROCEDURE WAS PERFORMED USING OUR OBTRYX DEVICE (ACTUAL DATE IS NOT KNOWN). POST PROCEDURE DURING FOLLOW UP VISIT (DATE IS NOT KNOWN), THE PHYSICIAN DISCOVERED A SMALL PIECE OF THE MESH EXTRUDING INTO THE PT'S VAGINA. THE PHYSICIAN TRIMMED THE MESH AND APPLIED ESTROGEN CREAM TO THE AREA. THE PHYSICIAN STATED THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTRYX MID-URETHRAL SLING SYSTEM FTL BOSTON SCIENTIFIC M0068504000

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention