BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2021531 · Received March 17, 2011

    Report

    Report Number
    3005099803-2011-00852
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX HALO TRANSOBTURATOR SLING SYSTEM WAS USED DURING A PROCEDURE. THIS IS THE SAME CASE AND PATIENT AS MFR REPORT # 3005099803-2011-00835. THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE PHYSICIAN HAD DIFFICULTY INITIALLY ADVANCING THE DELIVERY DEVICE ON THE FIRST SIDE, OR THE PATIENT'S RIGHT SIDE. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED TOUGH TISSUE AND PUNCTURED HIS FINGER WITH THE DELIVERY DEVICE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OBTRYX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068505000

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR