BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G30-01 VIS-RX MICRO-IMAGING CATHETER

    MDR report key: 25137320 · Received May 11, 2026

    Report

    Report Number
    3011578544-2026-00003
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    February 5, 2024
    Report Date
    February 5, 2024
    Manufacturer
    GENTUITY, LLC
    Product Code
    DQO
    UDI-DI
    00859910007018
    PMA / PMN Number
    K242239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A COMBINATION PRODUCT THE INVESTIGATION DETERMINED THAT INCREASED FRICTION IN THE CATHETER LED TO AN INCONSISTENT PULLBACK RESULTING IN THE REPEATED FRAMES CAPTURED DURING IMAGING.

    Description of Event or Problem · 0

    NMC COMPLAINT: (B)(4). OSTIAL LCX LESION. PULLBACK PERFORMED POST-INTERVENTION. DURING THE PULLBACK, THE PIM JAWS RELEASED, AND A KNOCKING SOUND WAS HEARD WHEN THE DEVICE WAS READVANCED. PULLBACK SHOWED MANY REPEATED FRAMES, AND THE REGION OF INTEREST WAS NOT CAPTURED. SIGNIFICANT OPTICAL PATH STRETCH WAS OBSERVED DURING THE ACQUISITION. BECAUSE OF THIS, THE POST-INTERVENTION ACQUISITION WAS REPEATED. IN THE REPEATED ACQUISITION, THE SAME EVENT OCCURRED AT THE VERY END OF THE RUN. THIS SECOND ACQUISITION WAS USABLE, WITH ONLY A FEW REPEATED FRAMES NOTED. THE VIS-RX CATHETER WAS INSPECTED AT THE END OF THE PROCEDURE, AND NO KINKS WERE OBSERVED. THE STAFF WAS ASKED TO SAVE THE CATHETER FOR RETURN SHIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52343 G30-01 VIS-RX MICRO-IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO GENTUITY, LLC G30-01 23H1605 00859910007018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown