BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM 3 MICRODELIVERY STENT SYSTEM

    MDR report key: 1203643 · Received October 6, 2008

    Report

    Report Number
    2939204-2008-00436
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 15, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INTERNAL CAROTID ARTERY (ICA) ANEURYSM STENT EMBOLIZATION PROCEDURE, THE "APPROX 20 CM DISTAL TO THE PROXIMAL SEGMENT" OF THE MICROCATHETER BROKE. THERE WERE NO REPORTED COMPLICATIONS DUE TO THIS EVENT, AND THE PT WAS IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM 3 MICRODELIVERY STENT SYSTEM (NJE) STENT INTRACRANIAL NJE NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. E345020 11346900

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR