BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON MICRO CATHETER

    MDR report key: 3052282 · Received April 11, 2013

    Report

    Report Number
    2029214-2013-00371
    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

    EVALUATION OF THE RETURNED DEVICE CONFIRMED THAT THE DISTAL TIP/MARKER BAND WAS NOT PRESENT ON DEVICE. BASED ON THE FINDINGS, THE CATHETER TIP MAY HAVE BEEN PARTIALLY SEPARATED DURING THE REMOVAL OF THE DEVICE FROM THE PACKAGE PRIOR TO USE. THIS CAN OCCUR WHEN THE USER DOES NOT PROPERLY REMOVE THE DEVICE FROM THE TIP PROTECTOR. THE LABEL ON THE DEVICE TRAY PROVIDES INSTRUCTIONS/DIAGRAMS REGARDING THE PROPER REMOVAL OF THE TIP FROM THE TIP PROTECTOR.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ICA (INTERNAL CAROTID ARTERY) PSEUDO ANEURYSM. DURING THE PROCEDURE, THE PHYSICIAN NAVIGATED THE ECHELON 90 CATHETER TO THE ANEURYSM AND NOTICED THAT THERE WAS NO DISTAL MARKER ON THE CATHETER. THE ECHELON WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NEW ECHELON.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155930 ECHELON MICRO CATHETER DELIVERY CATHETER KRA EV3 NEUROVASCULAR 190-5092-150 9610207

    Patients

    Seq Age Sex Outcome Treatment
    1