BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 14 MICROCATHETER

    MDR report key: 17624504 · Received August 24, 2023

    Report

    Report Number
    MW5144968
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    August 20, 2023
    Report Date
    August 22, 2023
    Manufacturer
    MEDTRONIC, INC. /MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN USING AN ECHELON 14 MICROCATHETER (LOT #B543437, PART #190-5092-150) FOR TREATMENT OF A CEREBRAL ANEURYSM, THE DISTAL MICROCATHETER MARKER (TIP MARKER) WAS NOTED TO BE MISSING, PRESUMABLY DURING PRODUCTION AS THERE IS NO WAY TO REMOVE OR DISPLACE THIS MARKER. THERE WAS NO ADVERSE EVENT RELATED TO THIS, BUT GIVEN THE MARKEDLY DIMINISHED ABILITY TO SEE THE MICROCATHETER TIP, THERE WAS RISK OF ANEURYSM PERFORATION BY ADVANCING THE MICROCATHETER TOO DISTALLY DUE TO BEING UNABLE TO VISUALIZE OF THE LOCATION OF THE CATHETER TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958774 ECHELON 14 MICROCATHETER CATHETER, CONTINUOUS FLUSH KRA MEDTRONIC, INC. /MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR 190-5092-150 B543437

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Other