BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIS-RX MICRO-IMAGING CATHETER

    MDR report key: 25233141 · Received May 20, 2026

    Report

    Report Number
    3011578544-2026-00007
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    March 15, 2024
    Report Date
    March 15, 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

    THE CATHETER FAILED TO PULL BACK; OCT SHOWED FIBER STRETCH, ROTATIONAL INSTABILITY, AND NO LENS MOVEMENT, CONSISTENT WITH FRICTION CAUSING THE PIM JAWS TO OPEN AND THE PULLBACK TO STOP. TWO SUBSEQUENT PULLBACKS WITH A SECOND CATHETER WERE NORMAL, THOUGH THE FINAL RE-ADVANCE ISSUE ALSO SUGGESTED FRICTION.

    Description of Event or Problem · 0

    STUDY # (B)(6). THIS WAS A STUDY PT BY DR (B)(6) IN THE LAD. IT WAS THE 1ST CATHETER AND THE 1ST RUN ATTEMPTED. WE HEARD A SLIP, THEN THE KNOCKING, AND NO PULLBACK WAS RECORDED. WHEN I WENT TO EXCHANGE THE CATHETER, THE PULLER HAD NOT RETURNED THE LASER TO THE STARTING POSITION, I HAD TO PULL THE CATHETER OUT, REBOOT THE SYSTEM, AND GO WITH A NEW CATHETER. THE NEXT 2 RUNS WENT WELL, HOWEVER WHEN THE NURSE WENT TO REMOVE THE NEXT CATHETER AT THE END OF THE CASE, THE PULLER HAD NOT RETURNED EITHER. UNFORTUNATELY, THEY DID NOT SAVE THAT CATHETER. DR (B)(6) DID WANT THIS STATED ¿THE INNOMINATE SUBCLAVIAN ARTERY WAS VERY TORTUOUS, WHICH MAY HAVE CAUSED SOME ISSUES FOR THE CATHETER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559847 VIS-RX MICRO-IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO GENTUITY, LLC G30-01 24A2304 00859910007018

    Patients

    Seq Age Sex Outcome Treatment
    1