BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON MICRO CATHETER

    MDR report key: 3050435 · Received April 10, 2013

    Report

    Report Number
    2029214-2013-00359
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 27, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED FOR EVALUATION. THE CATHETER TIP WAS PARTIALLY SEPARATED AT THE POINT BETWEEN THE MARKER BAND AND THE END OF THE CATHETER BRAID. BASED ON THE INVESTIGATION, THE DAMAGE TO THE DISTAL TIP IS LIKELY TO HAVE OCCURRED AS A RESULT OF SHAPING THE TIP OF THE CATHETER WHICH ALLOWED THE GUIDEWIRE TO EXIT THROUGH THE LOCATION OF SEPARATION.(B)(4).

    Description of Event or Problem · 1

    DURING PREPARATION, IT WAS REPORTED THAT THE PHYSICIAN STEAM SHAPED THE TIP OF THE CATHETER AND THEN INSERTED THE GUIDEWIRE. UPON INSERTION, THE GUIDEWIRE PERFORATED THE CATHETER.NO INJURY WAS REPORTED WITH THE PATIENT AS THE EVENT OCCURRED OUTSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152142 ECHELON MICRO CATHETER DELIVERY CATHETER KRA EV3 NEUROVASCULAR 105-5091-150 9553196

    Patients

    Seq Age Sex Outcome Treatment
    1