BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 2001671 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00496
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE REVEALED NO DEFECTS. BOTH MESH CARRIERS FIT EASILY ONTO THE DELIVERY DEVICE AND DEPLOYED FREELY. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING RELATED POTENTIAL CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SINGLE INCISION SLING SYSTEM WAS USED DURING A MID-URETHRAL SLING PROCEDURE. ACCORDING TO THE COMPLAINANT, THE MESH CARRIER WAS LOADED ONTO THE DELIVERY DEVICE AND PLACED WITHIN THE PATIENT'S TRANSOBTURATOR MUSCLE ON THE FIRST SIDE. THE MESH CARRIER WAS FULLY SEATED ON THE DELIVERY DEVICE TIP PRIOR TO INSERTION AND THE MIDLINE MARKER WAS AT THE MIDLINE POSITION UNDER THE URETHRA. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE DELIVERY DEVICE, THE MESH CARRIER WOULD NOT RELEASE FROM THE DELIVERY DEVICE TIP. THE DELIVERY DEVICE AND MESH WERE REMOVED FROM THE PATIENT, AND THE PHYSICIAN WAS ABLE TO RELEASE THE MESH CARRIER FROM THE DELIVERY DEVICE TIP OUTSIDE OF THE PATIENT. HOWEVER, THE MESH FELL ON THE FLOOR WHEN THE CARRIER WAS RELEASED FROM THE DELIVERY DEVICE TIP. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A SECOND SOLYX SINGLE INCISION SLING SYSTEM. THERE WERE NO COMPLICATIONS 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 A SOLYX SINGLE INCISION SLING SYSTEM WAS USED DURING A MID-URETHRAL SLING PROCEDURE. ACCORDING TO THE COMPLAINANT, THE MESH CARRIER WAS LOADED ONTO THE DELIVERY DEVICE AND PLACED WITHIN THE PATIENT'S TRANSOBTURATOR MUSCLE ON THE FIRST SIDE. THE MESH CARRIER WAS FULLY SEATED ON THE DELIVERY DEVICE TIP PRIOR TO INSERTION AND THE MIDLINE MARKER WAS AT THE MIDLINE POSITION UNDER THE URETHRA. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE DELIVERY DEVICE, THE MESH CARRIER WOULD NOT RELEASE FROM THE DELIVERY DEVICE TIP. THE DELIVERY DEVICE AND MESH WERE REMOVED FROM THE PATIENT, AND THE PHYSICIAN WAS ABLE TO RELEASE THE MESH CARRIER FROM THE DELIVERY DEVICE TIP OUTSIDE OF THE PATIENT. HOWEVER, THE MESH FELL ON THE FLOOR WHEN THE CARRIER WAS RELEASED FROM THE DELIVERY DEVICE TIP. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A SECOND SOLYX SINGLE INCISION SLING SYSTEM. THERE WERE NO 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 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068507000 1ML0110103

    Patients

    Seq Age Sex Outcome Treatment
    1