BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM STENT

    MDR report key: 2181869 · Received July 28, 2011

    Report

    Report Number
    2939204-2011-00389
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    April 16, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. VISUAL INSPECTION OF THE RETURNED DEVICE DISCOVERED THAT THE MICRODELIVERY CATHETER WAS STRETCHED ON ITS PROXIMAL SHAFT UNDER THE STRAIN RELIEF AS WELL AS THE OUTER TUBING. DUE TO THE STRETCHING THE PROXIMAL SHAFT OUTER TUBING HAD ALSO SEPARATED, HOWEVER THE INNER BRAIDED TUBING WAS INTACT. SOME BLOOD WAS OBSERVED IN THE MICRODELIVERY CATHETER AND THE STABILIZER WAS RETURNED IN THE MICRODELIVERY CATHETER. THE STENT WAS NOTED TO BE PARTIALLY PROTRUDING THROUGH THE MICRODELIVERY CATHETER DISTAL END. THE STABILIZER WAS JAMMED IN THE MICRODELIVERY CATHETER AND KINKED ON ITS PROXIMAL SHAFT. DURING AN ATTEMPT TO REMOVE THE STABILIZER FROM THE MICROCATHETER, THE STABILIZER SEPARATED AT ITS PROXIMAL JUNCTION. NO OTHER ANOMALIES WERE OBSERVED. BASED ON ANALYSIS OF THE DEVICE AND THE AVAILABLE INFORMATION THERE IS NO INDICATION OF MISUSE, USER ERROR OR MISHANDLING WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THERE IS NO INFORMATION TO SUGGEST PRODUCT NONCONFORMANCE OR A TORTUOUS ANATOMY LEADING TO OPERATION ISSUES. THEREFORE THE CAUSE OF THE EVENT WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE REVEALED THE STENT HAD PARTIALLY DEPLOYED THROUGH THE TIP OF THE MICROCATHETER AND THAT THE MICROCATHETER HAD SEPARATED. THERE WAS NO CONSEQUENCE 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 M003E3300200 12711111

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR