BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITREX

    MDR report key: 17277288 · Received July 7, 2023

    Report

    Report Number
    17277288
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    February 6, 2023
    Report Date
    June 22, 2023
    Manufacturer
    COVIDIEN LLC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    [REDACTED NAME] WAS IMPLANTING A CARDIOMEMS WHEN THE TIP OF THE GUIDEWIRE SHEARED OFF INTO THE PULMONARY ARTERY. THE TIP OF THE WIRE WAS RETRIEVED. THERE WAS NO DEVIATION FROM PRACTICE. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED. THE WIRE WAS SEQUESTERED (EV3 NITREX GUIDEWIRE .018 X 300CM, LOT #7061881) PATIENT WAS DISCHARGED HOME THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422228 NITREX WIRE, GUIDE, CATHETER DQX COVIDIEN LLC N183002 7061881

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown