BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 2191989 · Received August 4, 2011

    Report

    Report Number
    3005099803-2011-02729
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE DISTAL TIP OF THE DELIVERY DEVICE HAD BROKEN OFF. THIS PORTION OF THE DEVICE WAS NOT RETURNED. ADDITIONALLY, THE CORNERS OF THE MESH BODY WERE FOUND PARTIALLY UNRAVELED. OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. THE FIRST SIDE OF THE SLING HAD BEEN IMPLANTED SUCCESSFULLY ON THE PATIENT'S RIGHT SIDE. WHEN THE PHYSICIAN ATTEMPTED TO IMPLANT THE SECOND SIDE (PATIENT'S LEFT SIDE), THE TIP DETACHED INSIDE THE MESH CARRIER. THE DELIVERY DEVICE WAS THEN PULLED OUT FROM THE PATIENT'S LEFT SIDE AND THE MESH CARRIER CAME OUT WITH THE DISTAL TIP OF THE DEVICE INSIDE IT. NO PART OF THE DEVICE FELL INSIDE THE PATIENT. THE IMPLANTED SIDE OF THE SLING WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN WAS HUGGING THE PUBIC RAMUS TIGHTLY WHEN THE DELIVERY DEVICE TIP DETACHED. THE MESH CARRIER WAS FULLY SEATED ON THE DELIVERY DEVICE TIP PRIOR TO INSERTION THROUGH THE VAGINAL INCISION. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE WITH NO PATIENT 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 SLING PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DISTAL TIP OF THE DELIVERY DEVICE DETACHED. THE FIRST SIDE OF THE SLING HAD BEEN IMPLANTED SUCCESSFULLY ON THE PATIENT'S RIGHT SIDE. WHEN THE PHYSICIAN ATTEMPTED TO IMPLANT THE SECOND SIDE (PATIENT'S LEFT SIDE), THE TIP DETACHED INSIDE THE MESH CARRIER. THE DELIVERY DEVICE WAS THEN PULLED OUT FROM THE PATIENT'S LEFT SIDE AND THE MESH CARRIER CAME OUT WITH THE DISTAL TIP OF THE DEVICE INSIDE IT. NO PART OF THE DEVICE FELL INSIDE THE PATIENT. THE IMPLANTED SIDE OF THE SLING WAS REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN WAS HUGGING THE PUBIC RAMUS TIGHTLY WHEN THE DELIVERY DEVICE TIP DETACHED. THE MESH CARRIER WAS FULLY SEATED ON THE DELIVERY DEVICE TIP PRIOR TO INSERTION THROUGH THE VAGINAL INCISION. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE WITH 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 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068507000 1ML1021608

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other