BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO NEURO GUIDEWIRE

    MDR report key: 1586899 · Received January 15, 2010

    Report

    Report Number
    2939204-2010-00083
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Date of Event
    August 22, 2009
    Report Date
    January 8, 2010
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510 (K): K002907. DEVICE MANUFACTURE DATE: UNKNOWN. ADDITIONAL INFORMATION RECEIVED STATED THE FOLLOWING: THE PATIENT'S ANATOMY WAS CONSIDERED VERY TORTUOUS, THE ROTATING HEMOSTASIS VALVES WERE ADEQUATELY TIGHTENED AND LOOSENED ACCORDING TO THE DIRECTIONS FOR USE (DFU) AND CONTINUOUS FLUSH WAS MAINTAINED. ANALYSIS OF THE DEVICE SHOWED THE GUIDEWIRE WAS SLIGHTLY BENT 4.0CM FROM ITS PROXIMAL END AND ON ITS MIDDLE AND DISTAL SECTIONS ALONG ITS LENGTH. VISUAL EXAMINATION OF THE GUIDEWIRE REVEALED THE PTFE COATING MISSING 76.0CM FROM ITS PROXIMAL END. MICROSCOPIC EXAMINATION REVEALED A WHITE COLORED MATERIAL WAS OBSERVED AT SEVERAL LOCATIONS ALONG THE GUIDEWIRE'S LENGTH. THE WHITE COLORED MATERIAL WAS MORE PREVALENT ON THE DISTAL 35CM LENGTH OF THE WIRE. FURTHER ANALYSIS WAS PERFORMED USING SCANNING ELECTRON MICROSCOPY (SEM), FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) AND ENERGY DISPERSIVE SPECTROSCOPY (EDS). THE FTIR SPECTROSCOPY REVEALED THE COMPOSITION OF THE WHITE-COLORED AREAS WERE NOT FOREIGN MATERIAL. SEM FURTHER CONFIRMED THE WHITE AREAS APPEARED TO HAVE BEEN DELAMINATION OF THE HYDROPHILIC COATING AND EDS IDENTIFIED PRESENCE OF CHLORINE ON MOST WHITE AREAS BELIEVED TO BE FROM SOME FORM OF A DISINFECTANT. IT WAS CONFIRMED BY THE USER FACILITY THAT THE DEVICE WAS STERILIZED PRIOR TO RETURN TO THE MANUFACTURER. BASED ON THE FTIR AND EDS RESULTS, IT CAN BE CONCLUDED THAT THE SOURCE OF THE WHITE MATERIAL WAS DUE TO DELAMINATION OF THE HYDROPHILIC COATING FROM THE DECONTAMINATION PROCESS PERFORMED AT THE USER FACILITY. IT WAS CONCLUDED THAT OPERATIONAL CONTEXT WAS MOST LIKELY THE CAUSE OF THE PTFE COATING DELAMINATION.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED GUIDEWIRE SHOWED POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS MISSING DUE TO DECONTAMINATION. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER SIMILAR DEVICE. THERE WAS NO ALLEGATION OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO NEURO GUIDEWIRE DQX NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NEUROFORM 3 STENT SYSTEM (BOSTON SCIENTIFIC)