BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX? BLUE

    MDR report key: 22523236 · Received July 16, 2025

    Report

    Report Number
    2124215-2025-45329
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Date of Event
    June 16, 2025
    Report Date
    August 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PAH
    UDI-DI
    08714729961901
    PMA / PMN Number
    K081275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    . DEVICE CODE A040609 CAPTURES THE REPORTABLE CODE OF SHAFT TIP BENT.

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A040609 CAPTURES THE REPORTABLE CODE OF SHAFT TIP BENT. UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS SOLYX BLUE DEVICE UNDERWENT A THOROUGH ANALYSIS. VISUAL INSPECTION FOUND THAT THE DELIVERY DEVICE TIP WAS BENT. A REVIEW OF THE DEVICE INSTRUCTIONS FOR USE (IFU) WAS COMPLETED AND DID NOT REVEAL ANY EVIDENCE OF DEVICE MISUSE, OFF LABEL USE, OR FAILURE TO FOLLOW INSTRUCTIONS. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE REPORTED EVENT OF "DELIVERY DEVICE TIP WAS BENT" WAS CONFIRMED. IT IS LIKELY THAT PROCEDURAL CONDITIONS, SUCH AS USER HANDLING TECHNIQUE DURING PLACEMENT OR ADVANCEMENT OF THE MESH WITH EXCESSIVE MANIPULATION OR FORCE RESULTED IN THE DELIVERY DEVICE TIP BECOMING BENT. A CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE WAS ASSIGNED TO THIS INVESTIGATION AS IT INDICATES THAT THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A SLING PROCEDURE USING A SOLYX BLUE DEVICE, THE NEEDLE TIP WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A SLING PROCEDURE USING A SOLYX BLUE DEVICE, THE NEEDLE TIP WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601769 SOLYX? BLUE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA PAH BOSTON SCIENTIFIC CORPORATION M0068507010 0035072113 08714729961901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown