BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNIPER®

    MDR report key: 23591765 · Received November 19, 2025

    Report

    Report Number
    23591765
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 1, 2025
    Report Date
    November 5, 2025
    Manufacturer
    EMBOLX, INC.
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE BALLOON OF THE MICROCATHETER BURST WHILE INFLATING THE BALLOON. THE MD WAS ABLE TO FINISH THE PROCEDURE WITH NO HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR BALLOON OCCLUSION MICROCATHETER, 150CM SNIPER BALLOON OCCLUSION MICROCATHETER, 45 DEGREE K TIP (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2872579 SNIPER® CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN EMBOLX, INC. SBC0629-KTP-150 EMX022425-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown