BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROFORM³¿

    MDR report key: 2853475 · Received November 30, 2012

    Report

    Report Number
    2939204-2012-00351
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 3, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (SUD)
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO ISSUES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. DEVICE ANALYSIS REVEALED THAT THE MICRODELIVERY CATHETER WAS KINKED AND STRETCHED. THE STABILIZER WAS COMPRESSED, KINKED AND SEPARATED. THE MICRODELIVERY CATHETER DISTAL LUMEN AND COATING WERE FOUND WITHIN SPECIFICATIONS. THE STENT WAS IN THE MICRODELIVERY CATHETER IN ITS INTENDED LOCATION. THE STENT WAS REMOVED FROM THE MICRODELIVERY CATHETER WITH A MANDREL AND FRICTION WAS ENCOUNTERED WHEN THE STENT WAS BEING PUSHED OUT. ALL DIMENSIONS WHICH COULD BE MEASURED ON THE MICRODELIVERY CATHETER, STABILIZER AND STENT WERE CONFORMING TO THEIR REQUIRED SPECIFICATIONS. THE DEVICE DAMAGES OBSERVED ARE INDICATIVE OF HIGH FRICTION DURING STENT DEPLOYMENT. THE ROOT CAUSE OF HIGH FRICTION DURING DEPLOYMENT CANNOT BE DEFINITIVELY DETERMINED IN THIS CASE. IDENTIFIED POSSIBLE CAUSES ARE: HIGHLY TORTUOUS ANATOMY; INADEQUATE FLUSH; MANUFACTURING DEFECTS IN STENT LOADING. BECAUSE OF THE HIGH FRICTION, THE USER MAY HAVE APPLIED EXCESSIVE FORCE BETWEEN THE STABILIZER AND THE CATHETER IN AN EFFORT TO DEPLOY THE STENT. THIS TENSILE FORCE IN THE CATHETER CAN CAUSE STRETCHING OF THE MICROCATHETER, AND THE CORRESPONDING COMPRESSIVE FORCE IN THE STABILIZER CAN CAUSE COMPRESSION IN THE STABILIZER, WHICH MAY MANIFEST ITSELF AS BUCKLING, BENDING, AND POSSIBLY KINKING AND BREAKAGE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ANATOMY WAS NOT TORTUOUS AND THAT CONTINUOUS FLUSH WAS MAINTAINED; THEREFORE, THESE COULD NOT BE IDENTIFIED AS THE PRIMARY CAUSE OR CONTRIBUTORS. BASED ON REVIEW OF ALL THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE DIFFICULTIES ENCOUNTERED DURING USE OF THE DEVICE AND DAMAGES OBSERVED DURING ANALYSIS CANNOT BE DEFINITELY DETERMINED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO ISSUES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. DEVICE ANALYSIS REVEALED THAT THE MICRODELIVERY CATHETER WAS KINKED AND STRETCHED. THE PROXIMAL SHAFT OUTER TUBING WAS SEPARATED AT THE STRETCHED AREAS, THOUGH THE INNER BRAIDED TUBING WAS STILL INTACT. THE STABILIZER WAS COMPRESSED, KINKED AND SEPARATED. THE MICRODELIVERY CATHETER DISTAL LUMEN AND COATING WERE FOUND WITHIN SPECIFICATIONS. THE STENT WAS IN THE MICRODELIVERY CATHETER IN ITS INTENDED LOCATION. THE STENT WAS REMOVED FROM THE MICRODELIVERY CATHETER WITH A MANDREL AND FRICTION WAS ENCOUNTERED WHEN THE STENT WAS BEING PUSHED OUT. ALL DIMENSIONS WHICH COULD BE MEASURED ON THE MICRODELIVERY CATHETER, STABILIZER AND STENT WERE CONFORMING TO THEIR REQUIRED SPECIFICATIONS. THE DEVICE DAMAGES OBSERVED ARE INDICATIVE OF HIGH FRICTION DURING STENT DEPLOYMENT. THE ROOT CAUSE OF HIGH FRICTION DURING DEPLOYMENT CANNOT BE DEFINITIVELY DETERMINED IN THIS CASE. IDENTIFIED POSSIBLE CAUSES ARE: HIGHLY TORTUOUS ANATOMY; INADEQUATE FLUSH; MANUFACTURING DEFECTS IN STENT LOADING. BECAUSE OF THE HIGH FRICTION, THE USER MAY HAVE APPLIED EXCESSIVE FORCE BETWEEN THE STABILIZER AND THE CATHETER IN AN EFFORT TO DEPLOY THE STENT. THIS TENSILE FORCE IN THE CATHETER CAN CAUSE STRETCHING OF THE MICROCATHETER, AND THE CORRESPONDING COMPRESSIVE FORCE IN THE STABILIZER CAN CAUSE COMPRESSION IN THE STABILIZER, WHICH MAY MANIFEST ITSELF AS BUCKLING, BENDING, AND POSSIBLY KINKING AND BREAKAGE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ANATOMY WAS NOT TORTUOUS AND THAT CONTINUOUS FLUSH WAS MAINTAINED; THEREFORE, THESE COULD NOT BE IDENTIFIED AS THE PRIMARY CAUSE OR CONTRIBUTORS. BASED ON REVIEW OF ALL THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE DIFFICULTIES ENCOUNTERED DURING USE OF THE DEVICE AND DAMAGES OBSERVED DURING ANALYSIS CANNOT NOT BE DEFINITELY DETERMINED.

    Description of Event or Problem · 1

    DEVICE ANALYSIS REVEALED THAT THE PROXIMAL SHAFT OUTER TUBING WAS SEPARATED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    DEVICE ANALYSIS REVEALED THAT THE PROXIMAL SHAFT OUTER TUBING WAS SEPARATED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM³¿ STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT (SUD) M003E3400200 14805851

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR