BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI STICK MAX

    MDR report key: 7577544 · Received June 6, 2018

    Report

    Report Number
    MW5077673
    Event Type
    Injury
    Date Received
    June 6, 2018
    Date of Event
    May 11, 2018
    Report Date
    May 31, 2018
    Manufacturer
    ANGIODYNAMICS, INC. / DBA NAVILYST MEDICAL, INC.
    Product Code
    DRE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MICROPUNCTURE WIRE FRACTURED WHILE INSIDE OF PATIENT, REQUIRING INCISION TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418947 MINI STICK MAX COAXIAL MICROINTRODUCER KIT DRE ANGIODYNAMICS, INC. / DBA NAVILYST MEDICAL, INC. 5304975

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention