BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOCROSS¿ ELITE

    MDR report key: 16252662 · Received January 27, 2023

    Report

    Report Number
    16252662
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Date of Event
    December 26, 2022
    Report Date
    January 18, 2023
    Manufacturer
    EV3, INC
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SURGEON INSERTED VASCULAR BALLOON INTO SUPERIOR FEMORAL ARTERY. WHEN TRIED TO REMOVE PRODUCT, THE ATTACHED REMOVAL STRING BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408111 NANOCROSS¿ ELITE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT EV3, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 28105 DA Unknown Other