BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G30-01 VIS-RX MICRO-IMAGING CATHETER

    MDR report key: 25282144 · Received May 26, 2026

    Report

    Report Number
    3011578544-2026-00021
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    May 7, 2024
    Report Date
    May 8, 2024
    Manufacturer
    GENTUITY, LLC
    Product Code
    NQQ
    PMA / PMN Number
    K230620
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SITE REPORTED THE CATHETER WAS STUCK IN THE PIM. THE USER POWERED DOWN THE SYSTEM AND REMOVED THE CATHETER WITH GUIDANCE. LOGS INDICATED SYMPTOMS CONSISTENT WITH A FAILED CATHETER, LIKELY DUE TO BUCKLING, CAUSING THE PIM JAWS NOT TO REMAIN FULLY FORWARD AND MAKING CATHETER EXTRACTION DIFFICULT. THE COMPLAINT IS CONFIRMED.

    Description of Event or Problem · 0

    I RECEIVED A PHONE CALL LAST NIGHT FROM LEAD TECH AT TGH. THE CATHETER WAS STUCK IN THE PIM. I INSTRUCTED HIM TO POWER DOWN THE SYSTEM AND REMOVE CATHETER ONCE SYSTEM WAS OFF. I WATCHED VIA FACETIME AND INSTRUCTED THEM ON HOW TO REMOVE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447482 G30-01 VIS-RX MICRO-IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC NQQ GENTUITY, LLC G30-01

    Patients

    Seq Age Sex Outcome Treatment
    1