BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNIPER SNIPER INFUSION CATHETER WITH BALLOON OCCLUSION, DUAL LUMEN, STRAIGHT TIP

    MDR report key: 22951393 · Received September 3, 2025

    Report

    Report Number
    22951393
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    August 25, 2025
    Report Date
    August 27, 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 MD ATTEMPTED TO UTILIZE THE EMBOLX SNIPER OCCLUSION MICROCATHETER. THE MD ATTEMPTED TO USE 4 DIFFERENT BALLOONS, WHICH RUPTURED EITHER DURING PREP OR IN THE PATIENT. THE CATHETERS WERE ALL REMOVED WITH NO REPORTED HARM TO THE PATIENT. THE REP [REPRESENTATIVE] WAS ON SITE AND HAS TAKEN TO DEFECTIVE BALLOONS BACK FOR EVALUATION. LOT NUMBERS EMX112124-02 (X 2); EMX122024-01; EMX070725-01. MANUFACTURER RESPONSE FOR VASCULAR INFUSION CATHETER WITH BALLOON OCCLUSION, DUAL LUMEN, STRAIGHT TIP, 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
    2332518 SNIPER SNIPER INFUSION CATHETER WITH BALLOON OCCLUSION, DUAL LUMEN, STRAIGHT TIP CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN EMBOLX, INC. SBC0629-STR-130 EMX112124-02; EMX122024-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown