BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COI

    MDR report key: 2030017 · Received March 25, 2011

    Report

    Report Number
    2939204-2011-00136
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K042539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. THE COIL WAS RETURNED SEPARATED FROM THE PUSHERWIRE AND WAS EXTENSIVELY STRETCHED AT THE PROXIMAL END. THE PUSHERWIRE WAS INSPECTED AND FOUND TO BE KINKED. THE PUSHERWIRE MOST LIKELY OCCURRED WHEN EXCESS FORCE WAS EXERTED ON THE PUSHERWIRE WHILE TRYING TO ADVANCE THE COIL. THE DISTAL TIP OF THE COIL WAS INSPECTED AND NO ANOMALIES NOTED THAT COULD HAVE CONTRIBUTED TO THE COIL GETTING STUCK AT THE DISTAL END OF THE MICROCATHETER. FROM THE ADDITIONAL INFORMATION, IT IS NOT KNOWN IF THE COIL WAS ROTATED OR RETRACTED IN A ONE TO ONE MOTION WITH THE DELIVERY WIRE AND IF THE COIL WAS INSERTED INTO THE ANEURYSM AT AN ACUTE ANGLE RELATIVE TO THE CATHETER TIP. EACH OF THESE COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. FROM THE INFORMATION AVAILABLE, THE MOST LIKELY ROOT CAUSE OF THIS ISSUE IS PROCEDURAL ISSUES ENCOUNTERED BY THE USER WHICH LIMITED THE PERFORMANCE OF THIS PRODUCT. AS A RESULT OF THIS INVESTIGATION A ROOT CAUSE OF OPERATIONAL CONTEXT WILL BE ASSIGNED. BASED ON THE INVESTIGATION AND THE INFORMATION PROVIDED, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY. FROM THE RESPONSES RECEIVED, IT WAS DETERMINED THAT THE PATIENT HAD A MILDLY TORTUOUS ANATOMY AND PREVIOUS COILS WERE DEPLOYED WITH THE SAME MICROCATHETER.

    Description of Event or Problem · 1

    WHILST REPOSITIONING THE DEVICE WITHIN THE ANEURYSM, THE COIL BECAME STUCK IN THE DISTAL END OF THE CATHETER. THE CATHETER AND COIL WERE REMOVED AS ONE UNIT. AS THE PUSHER WIRE WAS RETRACTED FROM THE CATHETER, THE COIL STRETCHED AND SEPARATED FROM THE PUSHER WIRE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    WHILST REPOSITIONING THE DEVICE WITHIN THE ANEURYSM, THE COIL BECAME STUCK IN THE DISTAL END OF THE CATHETER. THE CATHETER AND COIL WERE REMOVED AS ONE UNIT. AS THE PUSHER WIRE WAS RETRACTED FROM THE CATHETER, THE COIL STRETCHED AND SEPARATED FROM THE PUSHER WIRE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COI DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M00334811300

    Patients

    Seq Age Sex Outcome Treatment
    1 GDC COIL (BOSTON SCIENTIFIC)| RENEGADE MICROCATHETER (BOSTON SCIENTIFIC)