BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D'VILL INTRODUCER

    MDR report key: 17603667 · Received August 23, 2023

    Report

    Report Number
    1318694-2023-00007
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    July 20, 2023
    Report Date
    August 23, 2023
    Manufacturer
    NUMED, INC.
    Product Code
    DYB
    UDI-DI
    04046955128297
    PMA / PMN Number
    K171206
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO ISSUES WERE NOTED. THERE HAVE NO OTHER COMPLAINTS OF THIS NATURE RECEIVED ON THIS PRODUCT DEVICE LOT. A REVIEW WAS ALSO PERFORMED ON THE DILATOR COMPONENT USED IN THIS LOT OF DEVICES. THERE HAVE BEEN NO OTHER COMPLAINTS OF THIS NATURE FOR THIS COMPONENT LOT OF DILATORS. THE INTRODUCER WAS RETURNED TO NUMED ON 8/4/2023. THE DILATOR'S HUB IS DETACHED AND THE DISTAL END OF THE DILATOR IS ALSO DETACHED. BOTH BREAKS ARE CLEAN WITH NO STRETCHING EVIDENT. THE DILATOR WAS SLOWLY BENT UNTIL FAILURE. THE DILATOR BROKE INSTEAD OF KINKING (REFER TO BREAK PIC). A COMPARATIVE D'VILL WAS TESTED. THE DILATOR WAS SLOWLY BENT UNTIL FAILURE. AFTER REACHING A RADIUS OF UNDER 1 INCH, THE DILATOR KINKED WITHOUT FRACTURING (REFER TO COMPARATIVE PIC). A PULL TEST WAS PERFORMED ON THE JUNCTION BETWEEN THE DILATOR SHAFT AND THE LUER HUB. THE JUNCTION FAILED AT 23.059 LBF (102.61N), WHICH IS WELL ABOVE THE 15N ACCEPTANCE CRITERIA OUTLINED IN THE IN VITRO BENCH TESTING . THE SHAFT STRETCHED BEFORE FAILURE (REFER TO COMPARATIVE PULL TEST PIC). TESTING SHOWED THAT THE COMPLAINT DILATOR HAD BECOME BRITTLE. THIS IS CONSISTENT WITH EXTENDED EXPOSURE TO UV LIGHT. THE IFU HAS A STATEMENT THAT READS - "AVOID EXTENDED EXPOSURE TO LIGHT." THE COMPARATIVE DEVICE PERFORMED NORMALLY DURING THE KINK AND PULL TESTING.

    Description of Event or Problem · 0

    AS REPORTED TO NUMED BY THE DISTRIBUTOR / END USER - BACK END OF THE DILATOR HAD BROKEN OFF. UPON REMOVAL FROM THE BODY THEY FOUND THAT THE DISTAL TIP OF THE DILATOR WAS NO LONGER ATTACHED TO THE MAIN BODY OF THE DILATOR. THE DISTAL TIP OF THE DILATOR WAS SITTING IN THE L MAIN PULMONARY ARTERY STILL ON THE WIRE. THEY SPENT SEVERAL HOURS TRYING TO GET IT OUT UNSUCCESSFULLY. THE SNARE USED, CUT THROUGH THE DILATOR TIP AND BROKE IT INTO TWO MORE PIECES. THEY ENDED UP HAVING TO TRAP ONE PIECE UNDER A STENT IN THE ILIAC AND THE OTHER EMBOLIZED INTO A SMALL SUBSEGMENTAL PULMONARY ARTERY BRANCH, WHICH THEY EVALUATED BY CT AND FELT WAS HIGHER RISK TO REMOVE THAN TO LEAVE IN PLACE ON ANTICOAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035429 D'VILL INTRODUCER INTRODUCER DYB NUMED, INC. 700 DV-0214 04046955128297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention