BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIS-RX CATHETER

    MDR report key: 25335458 · Received May 29, 2026

    Report

    Report Number
    3011578544-2026-00038
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    September 12, 2022
    Report Date
    September 12, 2022
    Manufacturer
    GENTUITY, LLC
    Product Code
    DQO
    UDI-DI
    00859910007018
    PMA / PMN Number
    K192922
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER PRODUCED ¿MEASUREMENT DISABLED¿ ACROSS 40¿50 MM. INSPECTION FOUND TWO MINOR KINKS (~20 MM PROXIMAL TO THE SHALLOW DEPTH MARKER AND ~32 MM PROXIMAL TO THE TIP) ON THE CATHETER. LOOKING AT THE CATHETER UNDER A MICROSCOPY SHOWED AN INTACT LENS WITH GEL MIGRATION AT THE LENS REGION. MEASUREMENT DISABLEMENT IS CONFIRMED; ROOT CAUSE REMAINS UNDETERMINED.

    Description of Event or Problem · 0

    CATHETER #1) HAD A GOOD RUN, NOT HEAVILY CALCIFIED, TORTUOUS OR TIGHT, HOWEVER ¿MEASUREMENT DISABLED¿ SHOWED UP ON 40-50 MM OF THE RUN, RIGHT THROUGH THE LESION AND DISTAL/PROXIMAL LANDING ZONES. OFFERED A NEW CATHETER. CATHETER #2) CATHETER WOULD NOT PURGE. OFFERED A THIRD CATHETER AND THIS ONE WORKED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611415 VIS-RX CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO GENTUITY, LLC G30-01 22H0213 00859910007018

    Patients

    Seq Age Sex Outcome Treatment
    1