BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON MICRO CATHETER

    MDR report key: 2112996 · Received June 3, 2011

    Report

    Report Number
    2029214-2011-00129
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 4, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN EVALUATED. THE CATHETER TIP IS PARTIALLY SEPARATED AT THE POINT BETWEEN THE MARKER BAND AND THE END OF THE CATHETER BRAID. THIS SEPARATION IS LIKELY WHERE THE GUIDEWIRE WAS REPORTED TO HAVE EXITED. CATHETER LUMEN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDEWIRE WAS OBSERVED TO HAVE EXITED OUT OF THE CATHETER PRIOR TO THE DISTAL TIP. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON MICRO CATHETER DELIVERY CATHETER KRA EV3 NEUROVASCULAR 145-5091-150 9377789

    Patients

    Seq Age Sex Outcome Treatment
    1