BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2232418 · Received September 2, 2011

    Report

    Report Number
    3005099803-2011-02977
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S WEIGHT WAS REPORTED TO BE ABOUT (B)(6).

    Description of Event or Problem · 1

    THIS IS THE SAME CASE AND PATIENT AS MFR REPORT # 3005099803-2011-02978. THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX CURVED TRANSOBTURATOR SLING SYSTEM WAS USED DURING A SLING PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN BUTTONHOLED THE VAGINAL MUCOSA DURING IMPLANTATION OF THE MESH LEG ON THE PATIENT'S LEFT SIDE. THIS WAS NOTICED AFTER THE MESH LEG HAD BEEN PULLED THROUGH THE ABDOMEN. THE PHYSICIAN THEN DISENGAGED THE ASSOCIATION LOOP FROM THE DELIVERY DEVICE AND PULLED THE MESH LEG BACK THROUGH THE VAGINAL INCISION IN ORDER TO MAKE A SECOND ATTEMPT. THERE WAS DIFFICULTY PULLING THE MESH LEG THROUGH AND THE MESH SLEEVE BROKE LEAVING THE BLUE DILATOR AND ASSOCIATION LOOP IN THE PATIENT. THE PHYSICIAN REMOVED THE DETACHED PIECE FROM THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER OBTRYX CURVED SLING SYSTEM WITHOUT ANY OTHER COMPLICATIONS. THE PATIENT IS CURRENTLY REPORTED TO BE "DOING WELL." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068504000 1ML0093001

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R