BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 18527920 · Received January 17, 2024

    Report

    Report Number
    2124215-2024-00879
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    December 21, 2023
    Report Date
    January 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PAH
    UDI-DI
    08714729774044
    PMA / PMN Number
    K081275
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF PATIENT CODE E211401 CAPTURES THE REPORTABLE EVENT OF PERFORATION, ORGANS. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. IMDRF IMPACT CODE E1309 CAPTURES THE REPORTABLE EVENT OF URINARY RETENTION POST-VOID RESIDUAL VOLUME (PVR) RESULTING IN THE NEED FOR CATHETERIZATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SIS SYSTEM WAS USED DURING A STRESS URINARY INCONTINENCE PROCEDURE IN THE BLADDER, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO PUSH THE SOLYX ANCHOR INTO THE PERIURETHRAL TISSUE, IT PERFORATED THE BLADDER. THE PHYSICIAN ATTEMPTED TO POP THE ANCHOR INTO THE MUSCLES, HOWEVER, IT WAS NOT ADVANCING, AND WHEN TRIED TO REMOVE, THERE WAS RESISTANCE. WHEN THE PHYSICIAN HAD SUCCESSFULLY REMOVED THE ANCHOR, IT WAS NOTICED THAT THE MESH WAS STRETCHED FROM PULLING THE ANCHOR OUT OF THE BLADDER. ANOTHER SOLYX SIS SYSTEM WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE PATIENT HAD A LARGE BLOOD CLOT AND A BLADDER PERFORATION WHICH WAS CAUTERIZED USING A BUGBEE DURING CYSTOSCOPY. THE BLEEDING WAS CONTROLLED, AND A CATHETER WAS LEFT IN PLACE. THE DAY AFTER THE PROCEDURE, THE PATIENT HAD A 50% POST-VOID RESIDUAL (PVR), SO SHE WAS TAUGHT SELF-CATHETERIZATION AND SCHEDULED TO FOLLOW UP A WEEK LATER. WHEN THE SURGEON LAST SPOKE TO THE PATIENT ON (B)(6) 2024, SHE DID NOT NEED TO SELF-CATHETERIZE AND WAS ALSO NOT LEAKING; THE PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2063681 SOLYX SIS SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA PAH BOSTON SCIENTIFIC CORPORATION 850-700 0032496303 08714729774044

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention