BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI STICK MAX, COAXIAL MICROINTRODUCER KIT

    MDR report key: 10718718 · Received October 21, 2020

    Report

    Report Number
    MW5097399
    Event Type
    Injury
    Date Received
    October 21, 2020
    Date of Event
    October 13, 2020
    Report Date
    October 20, 2020
    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

    THE TIP OF A COAXIAL MICROINTRODUCER GUIDEWIRE BROKE OFF IN A PATIENT AS IT WAS BEING REMOVED FROM THE PATIENT DURING A HEART CATHETERIZATION PROCEDURE. THIS WILL REQUIRE INTERVENTION WHICH WILL BE DONE AS A NEEDED AV GRAFT REVISION/REPAIR PROCEDURE IS PERFORMED IN THE NEAR FUTURE. NO RELEVANT ASSESSMENTS TO ADD. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174066 MINI STICK MAX, COAXIAL MICROINTRODUCER KIT DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE NAVILYST MEDICAL INC./ANGIODYNAMICS, INC H965457490 5589155

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R