BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNIPER

    MDR report key: 14131795 · Received April 16, 2022

    Report

    Report Number
    3011660785-2022-00002
    Event Type
    Malfunction
    Date Received
    April 16, 2022
    Date of Event
    January 7, 2022
    Report Date
    April 15, 2022
    Manufacturer
    EMBOLX, INC.
    Product Code
    MJN
    UDI-DI
    00853359008032
    PMA / PMN Number
    K180904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION, THEREFORE A FAILURE ANALYSIS COULD NOT BE COMPLETED. USER FACILITY REPORT INDICATED NO PATIENT HARM. COMMUNICATIONS WITH PHYSICIANS AT THE USER FACILITY REVEALED NO KNOWLEDGE OF THIS OCCURRENCE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED PER HOSPITAL MEDWATCH REPORT #13450705 THAT THE HYDROPHILIC COATING ON THE CATHETER FAILED. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER OF THE SAME WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2414379 SNIPER BALLOON OCCLUSION CATHETER MJN EMBOLX, INC. SBC0629-STR-150 EMX060821-02 00853359008032

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown