BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 2083195 · Received May 10, 2011

    Report

    Report Number
    3005099803-2011-01647
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN, HOWEVER, IT WAS REPORTED THAT THE PATIENT IS OVER 18 YEARS. THE LOT NUMBER OF THE DEVICE IS UNKNOWN, HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SINGLE INCISION SLING SYSTEM WAS USED DURING A SLING PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DISTAL TIP OF THE DELIVERY DEVICE DETACHED INSIDE THE PATIENT. THIS OCCURRED ON THE SECOND SIDE OF IMPLANTATION WHICH WAS THE PATIENT'S RIGHT SIDE. IT WAS REPORTED THAT THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT'S ANATOMY, HOWEVER, THE PHYSICIAN ENCOUNTERED TOUGH TISSUE DURING ADVANCEMENT OF THE DELIVERY DEVICE. THE MESH CARRIER WAS FULLY SEATED ON THE DELIVERY DEVICE TIP AND THE PHYSICIAN DID NOT APPLY MORE THAN A NORMAL AMOUNT OF PRESSURE WHEN ADVANCING THE DEVICE. THE MIDLINE MARKER WAS AFTER THE MIDLINE POSITION UNDER THE URETHRA WHEN THE PROBLEM OCCURRED AND THE PHYSICIAN WAS NOT HOLDING ONTO THE MESH. THE PHYSICIAN SUCCESSFULLY REMOVED THE DETACHED PORTION OF THE DELIVERY DEVICE WITH HIS FINGERS. THE SLING WAS REMOVED FROM THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER SOLYX SINGLE INCISION SLING SYSTEM WITHOUT COMPLICATIONS. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention