BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO NYLON HELICAL DETACHABLE COIL

    MDR report key: 2983596 · Received February 28, 2013

    Report

    Report Number
    2029214-2013-00179
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    January 31, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COIL WAS RETURNED FOR EVALUATION AND THE PUSHER ASSEMBLY WAS FOUND TO BE DAMAGED. THE DETACHMENT STICK WAS FOUND BENT AND THIS LIKELY PREVENTED THE COIL FROM DETACHING. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A RIGHT PULMONARY ARTERY ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE CONCERTO IMPLANT COIL WAS ADVANCED THROUGH A .038ID DIAGNOSTIC CATHETER AND WAS NOT ABLE TO DETACH ONCE IT REACHED THE ANEURYSM. THE COIL WAS REMOVED FROM THE PATIENT. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86338 CONCERTO NYLON HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR NV-6-20-HELIX 9534787

    Patients

    Seq Age Sex Outcome Treatment
    1