BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXT DETACHABLE COIL, TETRIS

    MDR report key: 2180345 · Received July 27, 2011

    Report

    Report Number
    2029214-2011-00194
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 6, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE COIL PREMATURELY DETACHED DURING DELIVERY WITH HALF OF THE COIL INSIDE THE CATHETER AND THE OTHER HALF INSIDE THE ANEURYSM. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXT DETACHABLE COIL, TETRIS ELECTROLYTICALLY DETACHABLE COIL HCG EV3 NEUROVASCULAR N-5-10-T10-TC 9396451

    Patients

    Seq Age Sex Outcome Treatment
    1