BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM 3 EZ 3.5 X 20MM

    MDR report key: 3011624 · Received March 19, 2013

    Report

    Report Number
    3008853977-2013-00047
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC CORK, LTD
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS BROKEN AND THE DISTAL END OF THE INTRODUCER SHEATH WAS DAMAGED. THERE WERE NO OTHER ANOMALIES NOTED. THE DEFINITIVE CAUSE FOR THE BROKEN STENT COULD NOT BE DETERMINED, IT IS POSSIBLE THAT PROCEDURAL FACTORS ENCOUNTERED DURING THE USE OF THE DEVICE CONTRIBUTED TO THE BROKEN STENT. THEREFORE, IT WAS CONCLUDED THAT OPERATIONAL CONTEXT WAS THE MOST LIKELY CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE STENT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE STENT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113133 NEUROFORM 3 EZ 3.5 X 20MM STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC CORK, LTD 15363400

    Patients

    Seq Age Sex Outcome Treatment
    1