BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX BLUE

    MDR report key: 21538232 · Received March 6, 2025

    Report

    Report Number
    2124215-2025-12579
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Date of Event
    February 11, 2025
    Report Date
    September 2, 2025
    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 A150205 CAPTURES THE REPORTABLE EVENT OF DIFFICULT TO ADVANCE.

    Additional Manufacturer Narrative · 0

    BLOCK H11: UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THE SOLYX BLUE DEVICE UNDERWENT A THOROUGH ANALYSIS. DURING THE PRODUCT ANALYSIS, IT WAS OBSERVED THAT THE MESH CARRIER WAS DETACHED, AND THE MESH WAS STRETCHED, CONFIRMING THE COMPLAINT. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, GIVEN THAT MESH PLACEMENT IS LARGELY A BLIND PROCEDURE IN WHICH TOUGH MUSCLE, SOME BONE, AND OCCASIONALLY TENDONS MAY BE ENCOUNTERED, CREATING RESISTANCE DURING PLACEMENT--CONTRIBUTED TO THE ISSUE, A CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE WAS ASSIGNED TO THIS INVESTIGATION SINCE THE ADVERSE EVENTS OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON EVENT. BLOCK H6: DEVICE CODE A150205 CAPTURES THE REPORTABLE EVENT OF DIFFICULT TO ADVANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A PROCEDURE USING A SOLYX BLUE DEVICE, THE DEVICE HAD DIFFICULTY ADVANCING. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A PROCEDURE USING A SOLYX BLUE DEVICE, THE DEVICE HAD DIFFICULTY ADVANCING. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487397 SOLYX BLUE MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA PAH BOSTON SCIENTIFIC CORPORATION M0068507010 0034957500 08714729961901

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown