BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON MICRO CATHETER

    MDR report key: 3052351 · Received April 11, 2013

    Report

    Report Number
    2029214-2013-00372
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER HAS BEEN EVALUATED AND THE TIP SEGMENT DISTAL TO THE MARKER BAND WAS STRETCHED AND PARTIALLY SEPARATED WHICH ALLOWED THE GUIDEWIRE TO EXIT THROUGH THE LOCATION OF SEPARATION.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A SIDEWALL ANEURYSM WITH INTENTION TO OCCLUDE THE VERTEBRAL ARTERY. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN NOTICED THE AGILITY WIRE HAD EXITED THE CATHETER PRIOR TO THE DISTAL TIP OF THE CATHETER. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156283 ECHELON MICRO CATHETER DELIVERY CATHETER KRA EV3 NEUROVASCULAR 145-5092-150 9669599

    Patients

    Seq Age Sex Outcome Treatment
    1