BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET COIL

    MDR report key: 2103250 · Received May 25, 2011

    Report

    Report Number
    2939204-2011-00304
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ONLY THE DELIVERY WIRE AN INTRODUCER SHEATH WERE RETURNED FOR EVALUATION. THE DELIVERY WIRE WAS FOUND TO BE KINKED AT 82CM, 97.4CM AND 173.5CM FROM THE PROXIMAL END. EXAMINATION UNDER MAGNIFICATION FOUND THAT IT WAS EVIDENT THAT THE COIL HAD SEPARATED FROM THE DELIVERY WIRE AT THE DETACHMENT ZONE. NO OTHER ANOMALIES WERE NOTED. IT WAS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE DIFFICULTIES ENCOUNTERED BUT BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION IT IS LIKELY THAT THE MULTIPLE DETACHMENT ATTEMPTS HAD WEAKENED THE DETACHMENT ZONE AND THIS BROKE AS THE DEVICE WAS BEING WITHDRAWN. THEREFORE, IT WAS CONCLUDED THAT OPERATIONAL CONTEXT CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY STATES THAT CONTINUOUS FLUSH WAS MAINTAINED AND THE MARKERS WERE ALIGNED CORRECTLY PRIOR TO ATTEMPTING TO DETACH THE COIL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD UNSUCCESSFULLY ATTEMPTED TO DETACH THE COIL INSIDE THE ANEURYSM. AS THE PHYSICIAN WAS REMOVING THE COIL FROM THE PATIENT IT DETACHED INSIDE THE MICROCATHETER. THE COIL WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER AS ONE UNIT WITH NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN HAD UNSUCCESSFULLY ATTEMPTED TO DETACH THE COIL INSIDE THE ANEURYSM. AS THE PHYSICIAN WAS REMOVING THE COIL FROM THE PATIENT IT DETACHED INSIDE THE MICROCATHETER. THE COIL WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER AS ONE UNIT WITH NO CLINCAL 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 M0035432010 13981591

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR 6 COILS (MODEL AND MANUFACTURER UNKNOWN)| EXCELSIOR SL10 MICROCATHETER (BOSTON SCIENTIFIC)