BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIS-RX MICRO-IMAGING CATHETER

    MDR report key: 25305329 · Received May 27, 2026

    Report

    Report Number
    3011578544-2026-00028
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    August 20, 2024
    Report Date
    August 20, 2024
    Manufacturer
    GENTUITY, LLC
    Product Code
    DQO
    UDI-DI
    00859910007018
    PMA / PMN Number
    K230620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CATHETER WAS REPORTED FOR BEING UNABLE TO PURGE. HOWEVER UPON TESTING THE RETURNED CATHETER IT PURGED AND THE MANUAL PULLBACK WORKED. INSPECTION FOUND THE LENS MARKER POSITIONED 3 MM FROM THE PEEK END (SPEC 6 ±1 MM) AND A MALFORMED O-RING CAUSING THE PURGE STRAIN RELIEF TO BE IMPROPERLY ATTACHED AND EASILY DISLODGED. THE PURGE FAILURE WAS UNCONFIRMED; THE STRAIN-RELIEF DEFECT IS A MANUFACTURING ISSUE AND IS CONFIRMED.

    Description of Event or Problem · 0

    THE PHYSICIAN AND STAFF WERE UNABLE TO PURGE CATHETER. THE GREEN PORTION OF THE CATHETER ALSO "BROKE OFF" ACCORDING TO THEIR NOTE. IT APPEARS TO HAVE POPPED OFF BUT IS STILL ATTACHED. THEY USED A SECOND CATHETER WERE ABLE TO DO PULLBACKS HOWEVER THEY HAD TROUBLE REMOVING THE CATHETER AFTER THE CASE. IT WAS STUCK IN THE JAWS. THEY SHUT DOWN THE SYSTEM AND WAS ABLE TO PULL CATHETER FREE FROM SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581899 VIS-RX MICRO-IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO GENTUITY, LLC G30-01 24G0300 00859910007018

    Patients

    Seq Age Sex Outcome Treatment
    1