BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNIPER

    MDR report key: 24947970 · Received April 21, 2026

    Report

    Report Number
    3011660785-2026-00001
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 21, 2026
    Manufacturer
    EMBOLX, INC.
    Product Code
    MJN
    UDI-DI
    00853359008049
    PMA / PMN Number
    K180904
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    USER FACILITY: (B)(6).

    Description of Event or Problem · 0

    BALLOON POPPED SHORTLY AFTER INFLATION. DOCTOR REPEATED THE PROCESS WITH A SECOND CATHETER WITH THE SAME OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411487 SNIPER BALLOON OCCLUSION CATHETER MJN EMBOLX, INC. SBC0629-STR-130 EMX102125-01 00853359008049

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown