BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNIPER

    MDR report key: 23432378 · Received October 30, 2025

    Report

    Report Number
    3011660785-2025-00001
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    August 1, 2025
    Report Date
    October 30, 2025
    Manufacturer
    EMBOLX, INC.
    Product Code
    MJN
    UDI-DI
    085335900849
    PMA / PMN Number
    K180904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DESCRIBE THE EVENT OR PROBLEM: THE BALLOON OF THE BALLOON OCCLUSION MICROCATHETER RUPTURED WHILE IN THE PATIENT. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME CATHETER, AND THIS BALLOON ALSO RUPTURED. THERE WAS NO REPORTED HARM TO THE PATIENT. LOTS: LOT 1: EMX122024-01; LOT 2: EMX012425-02.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357009 SNIPER BALLOON OCCLUSION CATHETER MJN EMBOLX, INC. SBC0629-STR-130 EMX122024-01 085335900849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown