BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON MICRO CATHETER

    MDR report key: 2190963 · Received August 4, 2011

    Report

    Report Number
    2029214-2011-00204
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR EVALUATION WITH THE DISTAL TIP MISSING. THE AMOUNT OF ONYX (LIQUID EMBOLIC) REFLUX WAS REPORTED TO BE 6-8 CM (PER IFU WARNING, "DO NOT ALLOW MORE THAN 1 CM OF ONYX TO REFLUX BACK OVER CATHETER TIP.") WHEN THE AMOUNT OF REFLUX IS GREATER THAN 1 CM, THIS CAN LEAD TO CATHETER TIP ENTRAPMENT AND DURING WITHDRAWAL, CATHETER SEPARATIONS CAN RESULT. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A DURAL ARTERIOVENOUS FISTULA WITH ONYX. IT WAS REPORTED THE CATHETER BROKE OFF AT APPROXIMATELY 1-2CM FROM THE DISTAL TIP DURING PROCEDURE. THE AMOUNT OF ONYX REFLUX WAS REPORTED TO BE APPROXIMATELY 6-8CM AND THE BROKEN PIECE REMAINED IN THE PATIENT. NO PATIENT INJURY REPORTED. SAME EVENT AS MDR# 2029214-2011-00205.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON MICRO CATHETER DELIVERY CATHETER KRA EV3 NEUROVASCULAR 105-5091-150 9446749

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability