BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON MICRO CATHETER

    MDR report key: 1755891 · Received June 24, 2010

    Report

    Report Number
    2029214-2010-00126
    Event Type
    Malfunction
    Date Received
    June 24, 2010
    Date of Event
    May 27, 2010
    Report Date
    May 28, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED.

    Description of Event or Problem · 1

    TREATMENT OF A SAH ANTERIOR COMMUNICATING ANEURYSM. IT WAS REPORTED AFTER THE ANEURYSM WAS TREATED, THE SYSTEM WAS REMOVED FROM THE PT AND THE GUIDEWIRE WAS OBSERVED TO HAVE PUNCTURED THE CATHETER PROXIMAL TO THE DISTAL TIP. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON MICRO CATHETER DELIVERY CATHETER KRA EV3 NEUROVASCULAR 105-5092-150 7379993

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR