BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 2470068 · Received February 27, 2012

    Report

    Report Number
    3005099803-2012-00654
    Event Type
    Injury
    Date Received
    February 27, 2012
    Report Date
    February 2, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 PLACEMENT PROCEDURE IN (B)(6) 2011 AFTER THE PATIENT PRESENTED WITH SUBJECTIVE SYMPTOMS OF STRESS URINARY INCONTINENCE (SUI). THE SLING PLACEMENT WAS COMPLICATED BY CYSTOSTOMY, BUT THE EXACT DETAILS ARE UNKNOWN. POST PROCEDURE, THE PATIENT HAD A FOLEY CATHETER IN PLACE FOR TWO WEEKS AND A NEGATIVE CYSTOGRAM AT THAT TIME OF FOLEY REMOVAL. THE PATIENT THEN DEVELOPED CONSTANT URINARY LEAKAGE REQUIRING 6-12 PADS. A REPEAT CYSTOGRAM SHOWED A FISTULA (EXACT DATE UNKNOWN). THREE MONTHS AFTER THE INITIAL SURGERY, A CYSTOSCOPY REVEALED EROSION OF MESH AT THE PROXIMAL URETHRA; THE MESH WAS SEEN PROTRUDING UNDER THE MUCOSA ON THE RIGHT SIDE OF THE BLADDER. THE PATIENT THEN UNDERWENT EXCISION OF THE MESH AND A CYSTOURETHROSCOPY. APPROXIMATELY 1.5 CM ON EACH SIDE OF THE SLING WAS DISSECTED FREE, AND ALL VISIBLE PORTIONS OF THE SLING WERE REMOVED. MARTIUS FLAP WAS USED TO COVER THE DEFECT. THE PATIENT WAS DISCHARGED ONE DAY AFTER THIS SURGERY AND WORE A FOLEY CATHETER FOR ONE MONTH. AFTER THE CATHETER WAS REMOVED, THE PATIENT CONTINUED TO EXPERIENCE MILD SUI REQUIRING ONE PAD A DAY. THE PATIENT IS CURRENTLY NOT SEEKING FURTHER SURGICAL INTERVENTION. THE FISTULA WAS REPORTED TO BE A DIRECT RESULT OF THE SLING PLACEMENT, BUT THE PATIENT'S MEDICAL CONDITION PREOPERATIVELY WAS ALSO CONTRIBUTING FACTOR. THE PATIENT'S CURRENT CONDITION IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK660

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention