BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET¿

    MDR report key: 2213267 · Received August 16, 2011

    Report

    Report Number
    2939204-2011-00415
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE: (B)(6). ADDITIONAL INFORMATION FROM THE USER FACILITY STATED THAT THERE WERE NO DIFFICULTIES ADVANCING THE DEVICE TO THE ANEURYSM, THE ANATOMY WAS NOT CONSIDERED HIGHLY TORTUOUS AND CONTINUOUS FLUSH WAS MAINTAINED. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. MICROSCOPIC INSPECTION OF THE RETURNED DEVICE FOUND THE MAIN COIL WAS STRETCHED AND ENTANGLED. THE COIL WAS INTACT AND WAS NOT FOUND TO BE BROKEN AS REPORTED. BASED ON THE INFORMATION PROVIDED, THE DEVICE WAS USED IN ACCORDANCE WITH THE LABELING. THE COIL STRETCHED MOST LIKELY DUE TO RESISTANCE ENCOUNTERED WHEN REPOSITIONING THE COIL. THE EXACT CAUSE OF THE RESISTANCE COULD NOT BE DETERMINED BUT IT MOST LIKELY DUE TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE COIL WAS BEING REPOSITIONED, RESISTANCE WAS ENCOUNTERED AND THE COIL STRETCHED AND BROKE. THE PROXIMAL PART OF THE COIL WAS REMOVED WITH THE PUSHER WIRE AND THE DISTAL PART WAS REMOVED USING A SNARE DEVICE. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE COIL WAS BEING REPOSITIONED, RESISTANCE WAS ENCOUNTERED AND THE COIL STRETCHED AND BROKE. THE PROXIMAL PART OF THE COIL WAS REMOVED WITH THE PUSHER WIRE AND THE DISTAL PART WAS REMOVED USING A SNARE DEVICE. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET¿ DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M0035464100 0014165645

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXCELSIOR SL10 MICROCATHETER (BOSTON SCIENTIFIC)