BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNIPER BALLOON OCCLUSION MICROCATHETER

    MDR report key: 16487181 · Received March 2, 2023

    Report

    Report Number
    MW5115428
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    January 27, 2023
    Report Date
    February 28, 2023
    Manufacturer
    EMBOLX, INC.
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PERFORMING ALCOHOL ABLATION WITH MD. REPRESENTATIVE/CEO OF EMBOLX COMPANY BROUGHT IN SNIPER BALLOON OCCLUSION MICROCATHETER 165 CM TO BE USED FOR PROCEDURE; REPRESENTATIVE REMAINED IN PROCEDURE. AFTER SECOND INFLATION OF THE BALLOON, THE BALLOON WOULD NOT DEFLATE AND IT BECAME LODGED IN VESSEL AND RUPTURED IN VEIN. NO HARM CAME TO PATIENT AND NO FRAGMENTS WERE LEFT BEHIND. REPRESENTATIVE WAS AWARE OF BALLOON RUPTURE AND TOOK THE RUPTURED BALLOON WITH HIM/HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736329 SNIPER BALLOON OCCLUSION MICROCATHETER CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN EMBOLX, INC. SBC0629-STR-165 EMX010923-01

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention