BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIS-RX PRIME MICRO-IMAGING CATHETER

    MDR report key: 25334761 · Received May 29, 2026

    Report

    Report Number
    3011578544-2026-00037
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    February 26, 2026
    Report Date
    February 27, 2026
    Manufacturer
    GENTUITY, LLC
    Product Code
    DQO
    UDI-DI
    00859910007155
    PMA / PMN Number
    K242966
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED REPEAT-FRAME FAILURE COULD NOT BE REPRODUCED; ROOT CAUSE IS UNDETERMINED AND THE COMPLAINT IS UNCONFIRMED. THE INVESTIGATION OF THE RETURNED CATHETER SHOWED THAT THE MANUAL PULLBACK WAS SMOOTH, PURGE SUCCEEDED, AND VLD WAS VISIBLE AT THE TIP INDICATING NO FIBER BREAKS. A KINK WAS NOTED 450 MM FROM THE GREEN CONE, BUT BENCH AND PHANTOM PULLBACKS PRODUCED CLEAR IMAGES AND NO REPEATED FRAMES.

    Description of Event or Problem · 0

    THE CATHETER DID NOT PULLBACK. ALL FRAMES IN THE ENTIRE PB WERE REPEAT FRAMES. WHEN THE CATHETER WAS REMOVED FROM THE BODY, THERE WERE NO VISIBLE KINKS OR FRACTURE. THE LENS WAS IN THE CORRECT LOCATION, AND STILL VERY BRIGHT, PIM. REPLACED WITH NEW CATHETER, SAME LOT#, AND REBOOTED SYSTEM. 2ND CATHETER WORKED APPROPRIATELY. CATHETER IS BEING RETURNED RGA # 0503. OBTAINED LOGS AND OCT PULLBACKS FROM CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611275 VIS-RX PRIME MICRO-IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO GENTUITY, LLC G31-01 25L0603 00859910007155

    Patients

    Seq Age Sex Outcome Treatment
    1