BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET COIL

    MDR report key: 2011577 · Received March 9, 2011

    Report

    Report Number
    2939204-2011-00108
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. DEVICE ANALYSIS REVEALED THAT THE FIRM COIL WAS SEPARATED FROM THE DELIVERY WIRE AT THE FIRM COIL JUNCTION. INFORMATION AVAILABLE INDICATED THAT NO ANOMALIES WERE NOTED TO THE DELIVERY WIRE PRIOR TO USE, CONTINUOUS FLUSH WAS MAINTAINED, THE PATIENT'S ANATOMY WAS NOT TORTUOUS, AND NO FRICTION OR RESISTANCE WAS EXPERIENCED DURING COIL ADVANCEMENT AND RETRACTION WITHIN THE MICROCATHETER. BASED ON THE INFORMATION AVAILABLE, IT IS PROBABLE THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE SEPARATION OF THE FIRM COIL FROM THE DELIVERY WIRE DURING REMOVAL. THEREFORE, A ROOT CAUSE OF OPERATIONAL CONTEXT WILL BE ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST SUCCESSFULLY IMPLANTING THE COIL INTO THE ANEURYSM; THE DELIVERY WIRE BROKE WITHIN THE MICROCATHETER. THE PUSHERWIRE WAS REMOVED AND THERE WAS NOT CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST SUCCESSFULLY IMPLANTING THE COIL INTO THE ANEURYSM; THE DELIVERY WIRE BROKE WITHIN THE MICROCATHETER. THE PUSHERWIRE WAS REMOVED AND THERE WAS NOT CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET COIL DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M0035474100 0013942514

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR EXCELSIOR MICROCATHETER (BOSTON SCIENTIFIC)