BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX VESSEL PREP SYSTEM

    MDR report key: 21412984 · Received February 19, 2025

    Report

    Report Number
    3012696653-2025-00001
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    December 18, 2024
    Report Date
    February 19, 2025
    Manufacturer
    VENTUREMED GROUP, INC.
    Product Code
    PNO
    UDI-DI
    00863656000318
    PMA / PMN Number
    K202187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER APPLICATION WITH FLEX, A PSEUDOANEURYSM WITH CONTRAST MEDIUM LEAKAGE FORMS AFTER THE ACTUAL STENOSIS IN THE STRAIGHT SEGMENT. EVEN INSERTING AN OCCLUSION BALLOON CANNOT STOP THE BLEEDING, WHICH IS WHY SURGICAL INTERVENTION WAS NECESSARY. DURING THE OPEN PROCEDURE, THE SURGEON DESCRIBED THIS RUPTURE AS A SLIT SEVERAL CM (APPROX. 4 CM) LONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41571 FLEX VESSEL PREP SYSTEM PERIPHERAL INTRAVASCULAR CATHETER PNO VENTUREMED GROUP, INC. FSC 4-40 63495 00863656000318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GUIDEWIRE| PTA BALLOON