BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV3 ECHELON - 14 MICRO CATHETER

    MDR report key: 1562932 · Received December 15, 2009

    Report

    Report Number
    MW5014014
    Event Type
    Malfunction
    Date Received
    December 15, 2009
    Date of Event
    December 11, 2009
    Report Date
    December 15, 2009
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING NEURO INTERVENTIONAL CASE, MICRO CATHETER SHEARED OFF LEAVING DISTAL FRAGMENT IN PT. PHYSICIAN INSERTED SNARE AND RETRIEVED SHEARED DISTAL FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EV3 ECHELON - 14 MICRO CATHETER ECHELON 14 MICRO CATHETER KRA MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 7825556

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR