BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIS-RX MICRO-IMAGING CATHETER

    MDR report key: 25306005 · Received May 27, 2026

    Report

    Report Number
    3011578544-2026-00030
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    November 21, 2024
    Report Date
    November 26, 2024
    Manufacturer
    GENTUITY, LLC
    Product Code
    DQO
    PMA / PMN Number
    K230620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OCT REVIEW SHOWED REPEATED FRAMES AND SEGMENTS WHERE THE LENS DID NOT MOVE, INDICATING PULLBACK STOPPAGE. NO LOGS OR CATHETER WERE PROVIDED FOR FURTHER ANALYSIS. IT IS SUSPECTED BUT NOT CONFIRMED BASED OFF OF THE OCT REVIEW THAT FRICTION CAUSED THE PIM JAWS TO RELEASE CAUSING THE REPEATED FRAMES.

    Description of Event or Problem · 0

    CUSTOMER REACHED OUT SEEKING HELP INTERPRETING AN UNUSUAL OCT IMAGE APPEARANCE. UPON DATA REVIEW (OCT ACQUISITION POST STENTING), A VERY HIGH NUMBER OF REPEATED FRAMES WERE NOTICED THROUGHOUT THE ENTIRE DATA SET, INDICATING THAT SHORTLY AFTER THE BEGINNING OF THE ACQUISITION THE CATHETER PULLBACK STOPPED WITH THE PIM DISCONNECTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202317 VIS-RX MICRO-IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO GENTUITY, LLC G30-01

    Patients

    Seq Age Sex Outcome Treatment
    1