BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX VESSEL PREP¿ SYSTEM

    MDR report key: 22473502 · Received July 10, 2025

    Report

    Report Number
    3012696653-2025-00003
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    June 19, 2025
    Report Date
    July 10, 2025
    Manufacturer
    VENTUREMED GROUP, INC.
    Product Code
    PNO
    UDI-DI
    00863656000325
    PMA / PMN Number
    K202187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PERFORATION OCCURRED, PROCEDURE WAS COMPLETED USING A STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678383 FLEX VESSEL PREP¿ SYSTEM PERIPHERAL INTRAVASCULAR CATHETER PNO VENTUREMED GROUP, INC. FSC 4-75 65709 00863656000325

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention STENT.