BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNIPER

    MDR report key: 23568594 · Received November 17, 2025

    Report

    Report Number
    23568594
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    September 16, 2025
    Report Date
    October 29, 2025
    Manufacturer
    EMBOLX, INC.
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER PLACED INTO THE PATIENT, THE BALLOON ON THE MICROCATHETER RUPTURED. THE CATHETER WAS REMOVED AND REPLACED WITH NO REPORTED HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR VASCULAR INFUSION CATHETER WITH BALLOON OCCLUSION, DUAL LUMEN, 130CM SNIPER INFUSION CATHETER WITH BALLOON OCCLUSION, DUAL LUMEN, STRAIGHT TIP (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2872909 SNIPER CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN EMBOLX, INC. SBC0629-STR-130 EMX070725-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown