BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIS-RX MICRO-IMAGING CATHETER

    MDR report key: 25245812 · Received May 21, 2026

    Report

    Report Number
    3011578544-2026-00011
    Event Type
    Malfunction
    Date Received
    May 21, 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

    THE FIRST PULLBACK WAS INCOMPLETE WHEN THE PIM JAWS OPENED AFTER 60 MM, PRODUCING REPEATED FRAMES AND RED FRAMES FROM STRETCH AND ROTATIONAL INSTABILITY. THREE SUBSEQUENT PULLBACKS WITH THE SAME CATHETER WERE SUCCESSFUL. RETURNED-UNIT TESTING SHOWED NO DEFECTS. THE COMPLAINT IS CONFIRMED AND FRICTION-RELATED ROOT CAUSE WAS INVESTIGATED UNDER CAPA C23-009.

    Description of Event or Problem · 0

    ¿CASE 7¿. LAD-PRE. IN THE FIRST 100 MM PULLBACK THE MOST PROXIMAL ~40 MM WERE MISSED DUE TO FRICTION ISSUES (PIM JAWS LET GO AND RED FRAMES APPEARED DUE TO ROTATIONAL INSTABILITY AND STRETCH). DID SHOCKWAVE AND NC BALLOONING ON A MID-LAD CALCIFIED PULLBACK. USING THE SAME CATHETER, THE OPERATOR DID A PULLBACK POST-, GOOD QUALITY. PLACED A 23 MM STENT. DID A THIRD PULLBACK WHICH WORKED FINE, BUT A FEW DISTAL FRAMES AT THE BEGINNING OF THE PULLBACK (9 CONSECUTIVE FRAMES) WERE LABELLED AS ¿RED FRAMES¿ WITH MEASUREMENTS DISABLED (SIGNIFICANT ROTATIONAL INSTABILITY IS VISIBLE). DID A LAST DIAGNOSTIC PULLBACK IN THE LCX, WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241121 VIS-RX MICRO-IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO GENTUITY, LLC G30-01 24A2304 00859910007018

    Patients

    Seq Age Sex Outcome Treatment
    1