BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBTRYX SYSTEM

    MDR report key: 2040246 · Received April 5, 2011

    Report

    Report Number
    3005099803-2011-01074
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K040787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING RELATED POTENTIAL CAUSE FOR THIS EVENT; THE TRAYS ARE 100% INSPECTED AFTER COMPLETION OF THE SEALING PROCESS. A VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE BOTTOM OF THE THERMOFORMED CLAM SHELL PACKAGING WAS MELTED. THE MELTED PORTION DID NOT APPEAR TO HAVE BREACHED THE PLASTIC WALL. THERE WERE NO DEFECTS NOTED ON ANY PART OF THE DEVICE. THE CAUSE FOR THE EVENT IS UNDETERMINABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX CURVED TRANSOBTURATOR SLING SYSTEM WAS UNPACKED DURING A REVISION SLING TRANSOBTURATOR TAPE PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, A PART OF THE TYVEK TRAY CONTAINING THE DEVICE APPEARED MELTED AND THE STERILITY OF THE DEVICE APPEARED COMPROMISED. THERE WERE NO HOLES IN THE TRAY OR THE OUTER BOX AND THERE WAS NO OTHER VISIBLE DAMAGE TO THE PACKAGING. IT IS UNKNOWN WHETHER THE BOX HAD BEEN EXPOSED TO HEAT. THE DEFECT ON THE TYVEK TRAY WAS NOTED IMMEDIATELY AFTER IT WAS REMOVED FROM THE BOX AND THERE WAS NO ATTEMPT TO OPEN THE TRAY. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER OBTRYX CURVED TRANSOBTURATOR SLING SYSTEM AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OBTRYX CURVED TRANSOBTURATOR SLING SYSTEM WAS UNPACKED DURING A REVISION SLING TRANSOBTURATOR TAPE PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, A PART OF THE TYVEK TRAY CONTAINING THE DEVICE APPEARED MELTED AND THE STERILITY OF THE DEVICE APPEARED COMPROMISED. THERE WERE NO HOLES IN THE TRAY OR THE OUTER BOX AND THERE WAS NO OTHER VISIBLE DAMAGE TO THE PACKAGING. IT IS UNKNOWN WHETHER THE BOX HAD BEEN EXPOSED TO HEAT. THE DEFECT ON THE TYVEK TRAY WAS NOTED IMMEDIATELY AFTER IT WAS REMOVED FROM THE BOX AND THERE WAS NO ATTEMPT TO OPEN THE TRAY. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER OBTRYX CURVED TRANSOBTURATOR SLING SYSTEM 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 M0068504000 1ML0120902

    Patients

    Seq Age Sex Outcome Treatment
    1