BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS MINI STICK MAX

    MDR report key: 9575621 · Received January 9, 2020

    Report

    Report Number
    MW5092150
    Event Type
    Injury
    Date Received
    January 9, 2020
    Date of Event
    December 20, 2019
    Report Date
    December 31, 2019
    Manufacturer
    NAVILYST MEDICAL, INC. / ANGIODYNAMICS, INC.
    Product Code
    DRE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FRACTURE OF MINI STICK MAX DURING LEAD CHANGE OUT. WIRE HAD TO BE SNARED TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30293 ANGIODYNAMICS MINI STICK MAX DILATOR, VESSEL FOR PERCUTANEOUS CATHETERIZATION DRE NAVILYST MEDICAL, INC. / ANGIODYNAMICS, INC. REF 45-759 5530160

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention