BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM STENT

    MDR report key: 2173892 · Received July 24, 2011

    Report

    Report Number
    2939204-2011-00379
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    May 26, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY. FROM THE RESPONSES RECEIVED IT WAS DETERMINED THAT NO DAMAGES WERE NOTED TO THE PACKAGING OR THE DEVICE DURING PREPARATION PRIOR TO PROCEDURE, CONTINUOUS FLUSH WAS MAINTAINED AND IT IS UNKNOWN IF THE PATIENT HAD A TORTUOUS ANATOMY. DEVICE ANALYSIS REVEALED A COMPRESSED DISTAL END, STRETCHED PROXIMAL END AND SEPARATED PROXIMAL END ON THE MICRODELIVERY CATHETER. THERE WAS SOME BLOOD IN THE MICRODELIVERY CATHETER. THE STABILIZER WAS BENT 4.0CM FROM THE PROXIMAL END AND KINKED ON THE PROXIMAL SHAFT 2.8CM FROM ITS PROXIMAL END. THE STENT COULD NOT BE DEPLOYED, BUT WAS REMOVED AND FOUND TO BE CONFORMING TO VISUAL AND DIMENSIONAL SPECIFICATIONS AS WELL AS THE 2 ROTATING HEMOSTASIS VALVES (RHVS) RETURNED ALONG WITH THE DEVICE. THE DAMAGES NOTED TO THE DEVICE ARE INDICATIVE OF FRICTION ENCOUNTERED DURING STENT SYSTEM ADVANCEMENT. THE CAUSE OF THIS COMPLAINT IS UNUSUALLY HIGH FRICTION BETWEEN THE STABILIZER, MICROCATHETER, AND/OR STENT IN THE SYSTEM. THE ROOT CAUSE OF HIGH FRICTION DURING DEPLOYMENT CANNOT BE DEFINITIVELY DETERMINED IN THIS CASE. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THE DEVICE WAS USED AGAINST INSTRUCTIONS FOR USE. BASED ON THE INVESTIGATION AND THE INFORMATION PROVIDED, THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    UPON ANALYSIS OF THE RETURNED DEVICE, IT WAS DISCOVERED THAT THE MICRODELIVERY CATHETER'S PROXIMAL OUTER SHAFT WAS STRETCHED AND SEPARATED DISTAL TO THE STRAIN RELIEF. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003E3350150 0014023161

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR