BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX VESSEL PREP SYSTEM

    MDR report key: 23689048 · Received December 1, 2025

    Report

    Report Number
    3012696653-2025-00004
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    October 30, 2025
    Report Date
    December 1, 2025
    Manufacturer
    VENTUREMED GROUP, INC.
    Product Code
    PNO
    UDI-DI
    0086365600325
    PMA / PMN Number
    K202187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    PHYSICIAN NOTED VESSEL DISSECTION REQUIRING FURTHER INTERVENTION INCLUDING STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2736607 FLEX VESSEL PREP SYSTEM PERIPHERAL INTRAVASCULAR CATHETER, PRODUCT CODE: PNO PNO VENTUREMED GROUP, INC. FSC 4-75 65719 0086365600325

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention STENT