BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G30-03 VIS-RX MICRO-IMAGING CATHETER

    MDR report key: 25222053 · Received May 19, 2026

    Report

    Report Number
    3011578544-2026-00005
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    January 11, 2024
    Report Date
    February 20, 2024
    Manufacturer
    GENTUITY, LLC
    Product Code
    DQO
    UDI-DI
    00859910007131
    PMA / PMN Number
    K230620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOUR CASES SHOWED 8¿10 MM OF REPEATED FRAMES AT PULLBACK START. OCT REVIEW SHOWED NO FRICTION ISSUES, ONLY REPEATED FRAMES. REPEATED FRAMES AT PULLBACK INITIATION ARE EXPECTED WHEN THE LENS DOES NOT MOVE IMMEDIATELY. THE COMPLAINT IS CONFIRMED.

    Description of Event or Problem · 0

    NME COMPLAINT (B)(4). STATIONARY IMAGE IN 4 PATIENTS FOR ALL THE PULLBACKS- WE COULD SEE THE SAME POSITION OF THE VESSEL MAINTAINED FOR 8-10 MM OVER THE DISTAL EDGE SEEN IN 90-100 MM OF THE PULLBACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87271 G30-03 VIS-RX MICRO-IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO GENTUITY, LLC G30-03 23M1300 00859910007131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown