BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI STICK MAX

    MDR report key: 23257701 · Received October 9, 2025

    Report

    Report Number
    MW5177137
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 1, 2025
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DRE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH A DIAGNOSIS OF ATHEROSCLEROSIS OF LEFT LOWER EXTREMITY WITH FIRST TOE ULCERATION ADMITTED FOR LEFT TRANSPOPLITEAL SUPERFICIAL FEMORAL ARTERY INTERVENTION. A COAXIAL MICROINTRODUCER (MINI STICK MAX) MANUFACTURED BY ANGIODYNAMICS INC WAS USED IN THE PROCEDURE (SPECIFIC INFORMATION IS ATTACHED). DURING THE PROCEDURE, A PORTION (7.62 CM) OF THE CATHETER BROKE OFF AND BECAME LODGED IN THE TISSUE SURROUNDING THE ARTERY. THE OBJECT COULD NOT BE RETRIEVED WITHOUT A SURGICAL PROCEDURE. THE PATIENT ELECTED NOT TO HAVE THE OBJECT REMOVED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483229 MINI STICK MAX DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE ANGIODYNAMICS, INC. H965457590

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other