BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G30-01 VIS-RX MICRO-IMAGING CATHETER

    MDR report key: 25283826 · Received May 26, 2026

    Report

    Report Number
    3011578544-2026-00023
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    May 9, 2024
    Report Date
    May 16, 2024
    Manufacturer
    GENTUITY, LLC
    Product Code
    DQO
    UDI-DI
    00859910007018
    PMA / PMN Number
    K230620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OCT DATA POINTS TO THE LENS NOT MOVING DURING PULLBACK, WHICH WOULD CONFIRM THE COMPLAINT THAT THERE WERE STACKING SLICES AND THE LENS DID NOT APPEAR TO PULLBACK. THE CATHETERS WERE NOT RETURNED. ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    NMC COMPLAINT # (B)(4). CATHETER PERFORMED PULLBACK BUT AT SOME POINT IT APPEARED THAT THE CONSOLE WAS STACKING REPEATED SLICES AND IMAGING THOUGH THE LENS WASNT PULLING BACK: THE CATHETER SHOULD HAVE PULLED BACK INTO THE GUIDE BUT DIDNT EVEN PULL BACK TO SEE THE PROXIMAL BRANCHES OF THE ARTERY THAT WERE WELL WITHIN THE 100MM OF THE PULLBACK.THE 40MM STENT THAT WAS PLACED WAS MEASURING OVER 80MM IN LENGTH IN BOTH OF THE POST RUNS. THEN, AS THE CATHETER TRIED TO ADVANCE THE LENS INTO READY POSITION KNOCKING WAS THEN HEARD FROM THE PIM AND THEN STOPPED AND GENERATED AN ERROR MESSAGE ON THE CONSOLE. ONCE THE CATHETER WAS DISCONNECTED THE PIM RESET ITSELF AND THE CATHETER WAS THEN RECONNECTED WITH A CRISP RED LIGHT NOTED AND ANOTHER RUN WAS COMPLETEED WITH THE SAME EVENTS AND ERRORS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360635 G30-01 VIS-RX MICRO-IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO GENTUITY, LLC G30-01 23M0700 00859910007018

    Patients

    Seq Age Sex Outcome Treatment
    1