BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI STICK MAX

    MDR report key: 11552454 · Received March 22, 2021

    Report

    Report Number
    MW5100163
    Event Type
    Injury
    Date Received
    March 22, 2021
    Date of Event
    March 17, 2021
    Report Date
    March 18, 2021
    Manufacturer
    NAVILYST MEDICAL, INC. /ANGIODYNAMICS, INC.
    Product Code
    DRE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE TO PLACE PERMACATH, THE SHEATH FROM THE MINI STICK MAX SEPARATED FROM THE HUB OF THE SHEATH WHILE IT WAS INSIDE OF THE PATIENT AND BECAME LODGED IN THE LEFT PULMONARY ARTERY. ATTEMPTS MADE TO REMOVE THE SHEATH WERE UNSUCCESSFUL. PATIENT WAS MOVED TO CT TO CONFIRM PLACEMENT AND INTERVENTIONAL RADIOLOGIST WAS CALLED-IN TO ATTEMPT REMOVAL, WHICH WAS SUCCESSFUL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445013 MINI STICK MAX DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE NAVILYST MEDICAL, INC. /ANGIODYNAMICS, INC. H965457530 5660512

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention