BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS MINI STICK MAX COAXIAL MICROINTRODUCER KIT

    MDR report key: 17918911 · Received October 12, 2023

    Report

    Report Number
    17918911
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    October 2, 2023
    Report Date
    October 11, 2023
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    DRE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MICROPUNCTURE USED FOR FEMORAL ARTERIAL ACCESS. WHEN GUIDEWIRE WAS BEING REMOVED, THE WIRE WAS STUCK. THE GUIDEWIRE WAS PULLED OUT AND A PIECE OF THE GUIDEWIRE BROKE OFF INSIDE THE PATIENT. VASCULAR CONSULTED TO ASSESS SITE, NO INTERVENTION NEEDED PER VASCULAR AND INTERVENTIONAL CARDIOLOGIST. RIGHT FEMORAL ARTERIAL SHEATH WAS REMOVED AND CLOSED WITH ANGIO-SEAL, WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132729 ANGIODYNAMICS MINI STICK MAX COAXIAL MICROINTRODUCER KIT DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE NAVILYST MEDICAL, INC. 45748 5793388

    Patients

    Seq Age Sex Outcome Treatment
    1 31025 DA Female