BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G31-01 VIS-RX PRIME MICRO-IMAGING CATHETER

    MDR report key: 25257256 · Received May 22, 2026

    Report

    Report Number
    3011578544-2026-00015
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 6, 2026
    Manufacturer
    GENTUITY, LLC
    Product Code
    DQO
    PMA / PMN Number
    K242966
    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 USER FAILED TO FOLLOW 008543 IFU VIS-RX PRIME AND PURGE THE CATHETER BEFORE CALIBRATION.

    Description of Event or Problem · 0

    TO START, WE HAD A CATHETER START A RUN WITH NO ISSUES, BUT THE LAST 30-40 MM HAD NO IMAGE AND DISPLAYED RED FRAMES. WHEN I WENT TO RELEASE THE CATHETER TO TROUBLESHOOT, I NOTICED IT WAS DIFFICULT TO RELEASE FROM THE PIM. I WILL BE SUBMITTING A COMPLAINT FOR THIS ISSUE. I HAVE THE TWO CATHETERS FROM THE CASE AND WILL BE SENDING THEM BACK FOR INSPECTION. I¿M NOT SURE WHICH ONE WAS THE CATHETER THAT GOT STUCK, HOWEVER IT SHOULD BE EASY TO IDENTIFY, AS THE SECOND CATHETER WE USED ENDED UP GETTING KINKED AT ONE POINT DUE TO RUSHING IN A HECTIC MOMENT. SO, WITH THAT BEING SAID, AFTER TROUBLESHOOTING WE DETERMINED THE CATHETER WAS BROKEN. WE DROPPED THE SECOND CATHETER ON THE FIELD. THEY INSERTED IT AND GOT A RUN; IT WAS PERFECT AND VERY USEFUL. HOWEVER QUICKLY AFTER THEY REALIZED THERE WAS A SIGNIFICANT AMOUNT OF AIR IN THE PATIENT¿S CORONARY. AFTER TENDING TO THE PATIENT, WHO THANKFULLY RECOVERED VERY QUICKLY, DR. (B)(6) MENTIONED HE DOES NOT LIKE THAT WE PURGE THE CATHETER DURING CALIBRATION. NEITHER (B)(6) OR I SAW THE FLUORO IMAGE AND IT WAS NOT CINED OR SAVED. AT FIRST, HE THOUGHT IT WAS THE PURGE DURING CALIBRATION. AFTER SOME DISCUSSION IT BECAME CLEAR THAT THE SCRUB TECH ONLY PURGED THE HOOP AND DR. (B)(6) THOUGHT HE WAS PURGING THE SIDE PORT. THEY RECOVERED THE PATIENT AND THE PATIENT DID FINE. WE WERE STILL WORKING FAIRLY QUICKLY AND, ON HIS POST, STENT RUN HE ENDED UP KINKING THE SECOND CATHETER (ALSO THE LAST CATHETER IN THEIR INVENTORY). AFTER THE CASE, WE WERE LUCKY ENOUGH TO TALK TO THE SCRUB TECH, HE TOLD US THERE WAS A LOT OF AIR IN THE CORONARY. I THOUGHT THAT SOUNDED ODD SINCE OUR CATHETER IS SO SMALL. I WENT BACK TO THE CONTROL ROOM AND SPOKE WITH THE FELLOW. HE SAID THAT THE SEGMENT FULL OF AIR WAS APPROX. 24-30MM LONG ON FLUORO. IT HIT ME THAT IT WAS NOT OUR CATHETER OR TECHNIQUE THAT CAUSED THE AIR EMBOLUS. PER OUR TRAINING, AND CONFIRMED WITH (B)(6), WE WERE TOLD THAT EVEN IF A FULL CATHETER OF AIR ACCIDENTALLY GOT INJECTED, THE AMOUNT WOULD BE NEGLIGIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611856 G31-01 VIS-RX PRIME MICRO-IMAGING CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO GENTUITY, LLC G31-01

    Patients

    Seq Age Sex Outcome Treatment
    1