BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUDEL DELIVERY SYSTEM

    MDR report key: 23777511 · Received December 11, 2025

    Report

    Report Number
    1318694-2025-00010
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    October 31, 2025
    Report Date
    December 11, 2025
    Manufacturer
    NUMED, INC.
    Product Code
    PNF
    PMA / PMN Number
    P150028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCTION TRAVELER (DHR) WAS REVIEWED AND NO ISSUES WERE FOUND. ALL DEVICES IN THIS LOT MET THE CRITERIA FOR RELEASE AND DISTRIBUTION. THERE ARE NO OTHER ASSOCIATED COMPLAINTS WITH THIS LOT OF DEVICES OR WITH THE COMPONENTS USED ON THE DEVICES. ALL COVERED STENTS ARE INSPECTED FOR THEIR COVERING AS PART OF FINAL INSPECTION. A SAMPLE FROM EACH LOT IS TESTED FOR COVERING STRENGTH. THE SAMPLE FROM THIS LOT FAILED AT 3.68 LBF, WELL ABOVE THE 1.5 LBF MINIMUM. THIS DEVICE WAS INTENTIONALLY BEING USED OFF-LABEL BY THE PHYSICIAN FOR A FONTAN PROCEDURE IN A CONDUIT THAT HAD ALREADY TORN. THIS DEVICE IS ONLY INDICATED FOR AORTIC AND RVOT USE. THE PHYSICIAN USED TWO NUDEL DEVICES OFF-LABEL ON THIS PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED. A COMPARATIVE DEVICE WAS PULLED AND TESTED. THE DEVICE WAS THE SAME CATALOG NUMBER AS THE COMPLAINT DEVICE, BUT A DIFFERENT LOT NUMBER. THE DEVICE WAS IMMERSED IN A BODY TEMPERATURE WATER BATH. THE SHEATH WAS PULLED BACK UNTIL THE BALLOON WAS EXPOSED. THE INNER BALLOON WAS INFLATED TO RBP (4.5ATM). THE OUTER BALLOON WAS THEN INFLATED TO RBP (3ATM). THE OUTER BALLOON MEASURED 22.24MM AT RBP. THE STENT COVERINGS FOUR GLUE SPOTS WERE INTACT, AND THERE WERE NO TEARS IN THE COVERING.

    Description of Event or Problem · 0

    FONTAN STENTING WITH NUDELS. THERE WAS A TEAR IN THE PREVIOUSLY PLACED CONDUIT. TRIED USING A NUDEL AND IT DIDN'T HELP. TRIED A SECOND NUDEL AND IT DIDN'T HELP. REMOVED CONDUIT AND THERE WAS A TEAR IN BOTH COVERINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2604193 NUDEL DELIVERY SYSTEM COVERED AORTIC STENT AND DELIVERY SYSTEM PNF NUMED, INC. 423.1 DEL-0819

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other