BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS MINI STICK MAX

    MDR report key: 11131474 · Received January 6, 2021

    Report

    Report Number
    MW5098704
    Event Type
    Injury
    Date Received
    January 6, 2021
    Date of Event
    December 7, 2020
    Report Date
    January 4, 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

    WHEN DILATOR FROM MINI STICK REMOVED, ONLY HALF OF THE DILATOR CATH WAS ON THE WIRE. SNARE WAS USED TO REMOVE TWO LARGER PIECES, AND STENT WAS USED TO PLACE THE REMAINING PIECE AGAINST THE ARTERIAL WALL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19260 ANGIODYNAMICS MINI STICK MAX DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE NAVILYST MEDICAL INC. / ANGIODYNAMICS, INC. H965457530 5627103

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention