BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX BLUE SYSTEM

    MDR report key: 21395466 · Received February 18, 2025

    Report

    Report Number
    2124215-2025-07879
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 27, 2025
    Report Date
    March 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729961932
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A150205 CAPTURES THE REPORTABLE EVENT OF DIFFICULT TO ADVANCE. PATIENT CODE E211401 CAPTURES THE REPORTABLE EVENT OF BLADDER PERFORATION. BLOCK H11: UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS LYNX BLUE SYSTEM UNDERWENT A THOROUGH ANALYSIS. VISUAL INSPECTION OF THE DEVICE REVEALED NO ISSUES. ADDITIONALLY, THE BLUE CENTERING TAB WAS ATTACHED, AND TWO DILATORS AND ASSOCIATION LOOPS WERE ALSO PRESENT. THE MESH HAD NO DEFECTS. BASED ON THE INFORMATION AVAILABLE, THE COMPLAINT WAS NOT CONFIRMED SINCE THE ANALYSIS OF THE RETURNED DEVICE DID NOT FIND ANY ISSUES WITH THE DEVICE. HOWEVER, SINCE THE ADVERSE EVENTS OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON EVENT, THE MOST PROBABLE CAUSE OF ADVERSE EVENT RELATED TO PATIENT CONDITION IS SELECTED SINCE AN EXISTING CONDITION OR DISEASE IS DEMONSTRABLY RESPONSIBLE FOR THE ADVERSE EVENT AND USE OF THE DEVICE HAS NEITHER CAUSED NOR OTHERWISE INFLUENCED THIS CONDITION/DISEASE-RELATED ADVERSE EVENT. BLOCK H11: CORRECTION TO BLOCK H6: PATIENT CODE.

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A150205 CAPTURES THE REPORTABLE EVENT OF DIFFICULT TO ADVANCE. PATIENT CODE E211401 CAPTURES THE REPORTABLE EVENT OF BLADDER PERFORATION. IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF PROCEDURE CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A PROCEDURE, A LYNX DEVICE WAS USED. DUE TO THE CHALLENGING ANATOMY, THE TROCAR INADVERTENTLY PUNCTURED THE BLADDER, CAUSING THE PROCEDURE TO BE HALTED AND RESCHEDULED TO ENSURE PATIENT SAFETY AND ALLOW FOR PROPER COMPLICATION MANAGEMENT. THE PHYSICIAN WAS PLANNING TO COMPLETE THE PROCEDURE ONCE THE PATIENT HEALS. CURRENTLY, THE PATIENT STILL PRESENTS THE STRESS URINARY INCONTINENCE SYMPTOMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A PROCEDURE, A LYNX DEVICE WAS USED. DUE TO THE CHALLENGING ANATOMY, THE TROCAR INADVERTENTLY PUNCTURED THE BLADDER, CAUSING THE PROCEDURE TO BE HALTED AND RESCHEDULED TO ENSURE PATIENT SAFETY AND ALLOW FOR PROPER COMPLICATION MANAGEMENT. THE PHYSICIAN WAS PLANNING TO COMPLETE THE PROCEDURE ONCE THE PATIENT HEALS. CURRENTLY, THE PATIENT HAS BEEN EXPERIENCING STRESS URINARY INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151570 LYNX BLUE SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068503010 0034919738 08714729961932

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention| O