BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 19643849 · Received July 1, 2024

    Report

    Report Number
    2124215-2024-40072
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 11, 2024
    Report Date
    August 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PAH
    UDI-DI
    08714729961901
    PMA / PMN Number
    K081275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF MESH/CARRIER ASSEMBLY FAILURE TO DEPLOY. BLOCK H11: UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS SOLYX SIS SYSTEM DEVICE UNDERWENT A THOROUGH ANALYSIS. VISUAL ANALYSIS OF THE DEVICE DID NOT FIND ANY DEFECTS ON THE DELIVERY DEVICE OF THE MESH. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS AND IS UNLIKELY TO HAVE AN ISSUE RELATED TO MANUFACTURING. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE DEVICE COMPLAINT OR PROBLEM COULD NOT BE CONFIRMED. A CONCLUSION CODE OF NO PROBLEM DETECTED WAS ASSIGNED TO THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF MESH/CARRIER ASSEMBLY FAILURE TO DEPLOY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A STRESS URINARY INCONTINENCE PROCEDURE USING A SOLYX SIS SYSTEM, THE SURGEON HAD DIFFICULTY LOADING THE DEVICE INTO THE TROCAR. THE DEVICE WAS EVENTUALLY PLACED BUT IT WOULD NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A STRESS URINARY INCONTINENCE PROCEDURE USING A SOLYX SIS SYSTEM, THE SURGEON HAD DIFFICULTY LOADING THE DEVICE INTO THE TROCAR. THE DEVICE WAS EVENTUALLY PLACED BUT IT WOULD NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572202 SOLYX SIS SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA PAH BOSTON SCIENTIFIC CORPORATION M0068507010 0033883521 08714729961901

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female