BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIS-RX MICRO-IMAGING CATHETER

    MDR report key: 25260164 · Received May 22, 2026

    Report

    Report Number
    3011578544-2026-00017
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    March 18, 2024
    Report Date
    March 18, 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

    THREE OF FOUR RCA PULLBACKS WERE INCOMPLETE WHEN THE PIM JAWS RELEASED AFTER 10¿70 MM, PRODUCING REPEATED FRAMES AND RED FRAMES FROM STRETCH AND ROTATIONAL INSTABILITY. THE SOFTWARE RECOVERY WORKFLOW ACTIVATED AS DESIGNED. THE COMPLAINT IS CONFIRMED.

    Description of Event or Problem · 0

    ¿CASE 17¿. RCA. DID PRE- AND POST-. DID 4 PULLBACKS. IN 3 PULLBACKS, THE PIM JAWS LET GO. IN THE FIRST 2 PULLBACKS, AFTER THE FIRST ~50- 70 MM OF PULLBACK. IN THE LAST CASE, AFTER ~10 MM. RED FRAMES DUE TO ROTATIONAL INSTABILITY AND STRETCH WERE VISIBLE, ESPECIALLY IN THE LAST RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574418 VIS-RX MICRO-IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO GENTUITY, LLC G30-01 24A2304 00859910007018

    Patients

    Seq Age Sex Outcome Treatment
    1