BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2153758 · Received July 8, 2011

    Report

    Report Number
    3005099803-2011-02359
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT OBTRYX HALO TRANSOBTURATOR MIDURETHRAL SLING SYSTEM WAS USED DURING A BLADDER NECK SUSPENSION PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN HAD DIFFICULTY INITIALLY ADVANCING THE DELIVERY DEVICE THROUGH THE OBTURATOR FORAMEN AND AROUND THE DESCENDING PUBIC RAMUS. THIS OCCURRED ON THE FIRST SIDE OF IMPLANTATION WHICH WAS THE PATIENT'S LEFT SIDE. IT WAS REPORTED THAT THE DISTANCE FROM THE PATIENT'S OUTSIDE SKIN SURFACE THROUGH THE OBTURATOR MUSCLES TO THE SPACE BEHIND THE PUBIC RAMUS WAS WIDER THAN THE DIAMETER OF THE CURVE OF THE DELIVERY DEVICE. IT WAS ALSO REPORTED THAT THE PATIENT WAS VERY OBESE AND HAD AN UNUSUALLY THICK DESCENDING PUBIC RAMUS. THE PHYSICIAN DID NOT ENCOUNTER TOUGH TISSUE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE 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 M0068505001 ML00000055

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR