BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNIPER

    MDR report key: 17649597 · Received August 30, 2023

    Report

    Report Number
    17649597
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    August 9, 2023
    Report Date
    August 11, 2023
    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

    DURING THE PREP OF THE MICROCATHETER, A PINHOLE LEAK IN THE BALLOON WAS DETECTED. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER CATHETER WITH NO HARM TO THE PATIENT. PER REPORT, SITE NOTIFIED THE MANUFACTURER DIRECTLY. MANUFACTURER RESPONSE FOR BALLOON OCCLUSION MICROCATHETER, SNIPER BALLOON OCCLUSION MICROCATHETER 2.9FR. 150CM (PER SITE REPORTER) SITE NOTIFIED MANUFACTURER REP DIRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314875 SNIPER CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN EMBOLX, INC. SBC0629-STR-150 EMX022023-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other