BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON MICRO CATHETER

    MDR report key: 2924270 · Received January 22, 2013

    Report

    Report Number
    2029214-2013-00058
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    December 26, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION.(B)(4).

    Description of Event or Problem · 1

    POST STEAM SHAPING, IT WAS REPORTED THAT THE CATHETER TIP BROKE OFF WHILE IT WAS STILL INSIDE THE SHAPING MANDREL.NO INJURY WAS REPORTED WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31283 ECHELON MICRO CATHETER DELIVERY CATHETER KRA EV3 NEUROVASCULAR 145-5092-150 9633782

    Patients

    Seq Age Sex Outcome Treatment
    1