BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIS-RX MICRO-IMAGING CATHETER

    MDR report key: 25246391 · Received May 21, 2026

    Report

    Report Number
    3011578544-2026-00013
    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

    MULTIPLE PULLBACKS WITH THE FIRST CATHETER WERE INCOMPLETE; THE PIM JAWS OPENED AFTER 20¿40 MM, PRODUCING REPEATED FRAMES AND RED FRAMES FROM STRETCH AND ROTATIONAL INSTABILITY. RETURNED-UNIT TESTING SHOWED NO DEFECTS WITH THE CATHETER. OCT LOG REVIEW CONFIRMED THE COMPLAINT.

    Description of Event or Problem · 0

    CASE #1 TIGHT OSTIAL LAD STENOSIS. THIS WAS A CASE INVOLVING PREVIOUS STENTS AT THE LEFT MAIN BIFURCATION (BOTH BALLOON AND STENTING). BOTH LAD AND LCX WERE PREVIOUSLY STENTED. THE OPERATOR PERFORMED ROTABLATOR AND BALLOON ANGIOPLASTY. ATTEMPTED HF-OCT POST-INTERVENTION. THE FIRST DID NOT PULL BACK (PIM JAWS LET GO; STRETCH AND ROTATIONAL INSTABILITY ARE VISIBLE IN THE IMAGES, RESULTING IN RED FRAMES, TOO). THIS HAPPENED IN BOTH THE LAD AND LCX. THE CATHETER WAS REPLACED, AND THE SECOND CATHETER PERFORMED OK IN THE LCX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188935 VIS-RX MICRO-IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO GENTUITY, LLC G30-01 24A2304 00859910007018

    Patients

    Seq Age Sex Outcome Treatment
    1