BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET COIL

    MDR report key: 2051040 · Received April 12, 2011

    Report

    Report Number
    2939204-2011-00213
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ONLY THE DELIVERY WIRE WAS RETURNED FOR ANALYSIS AND THIS WAS RETURNED WITH THE MICROCATHETER USED IN THE PROCEDURE, NO ANOMALIES WERE NOTED TO THE MICROCATHETER. THE MAIN COIL REMAINS IMPLANTED. VISUAL INSPECTION OF THE DEVICE NOTED THAT THE DEVICE WAS EXTENSIVELY STRETCHED ON THE INNER CLOSED PITCH COIL, DISTAL TO THE DETACHMENT ZONE. THE DETACHMENT ZONE WAS FRACTURED. THE POLYIMIDE (PI) COATING ON THE DELIVERY WIRE WAS DETACHED AS A RESULT OF THE EXCESSIVE STRETCHING OF THE INNER COIL. THE OUTER OPEN PITCH COIL AND PLATINUM MARKER COIL WERE INTACT AND UNDAMAGED. APPROXIMATELY 25CM OF THE INNER COIL, PROXIMAL TO THE PLATINUM MARKER COIL WAS ALSO INTACT. THE DELIVERY WIRE WAS KINKED IN SEVERAL LOCATIONS ALONG ITS LENGTH. EXAMINATION UNDER MAGNIFICATION CONFIRMED THE INNER CLOSED PITCH COIL DISTAL TO THE DETACHMENT ZONE WAS STRETCHED AND DETACHED FROM THE DELIVERY WIRE. FROM EXAMINATION OF THE DISTAL END OF THE DELIVERY WIRE IT WAS EVIDENT THAT THE MAIN COIL HAD DETACHED FROM THE DELIVERY WIRE AT THE DETACHMENT ZONE. THE PI COATING ON THE WIRE WAS NOTED TO BE EXTENDING FROM THE PEBAX AND TO BE BROKEN. THE FIRM COIL WAS EXTENSIVELY STRETCHED AND UNRAVELED FROM THE DETACHMENT ZONE. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION IT IS MOST LIKELY THAT THE DELIVERY WIRE STRETCHED AND BROKE AFTER RESISTANCE WAS ENCOUNTERED IN THE MICROCATHETER AS IT WAS BEING REMOVED FROM THE PATIENT. IT WAS CONCLUDED THAT THE MOST PROBABLE CAUSE FOR THE REPORTED EVENT AND OBSERVED DAMAGE TO THE DEVICE WAS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE COIL BROKE FROM THE PUSHER WIRE AND A LOOP OF THE COIL PROTRUDED INTO THE PARENT VESSEL. THE PHYSICIAN ATTEMPTED TO SECURE THE LOOP TO THE PARENT VESSEL WALL BUT THIS WAS NOT SUCCESSFUL. THE PROCEDURE WAS COMPLETED BY COILING THE ANEURYSM AND THE COIL LOOP REMAINED PROTRUDING INTO THE PARENT VESSEL. THE PATIENT WAS REPORTED TO BE NEUROLOGICALLY INTACT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE COIL BROKE FROM THE PUSHER WIRE AND A LOOP OF THE COIL PROTRUDED INTO THE PARENT VESSEL. THE PHYSICIAN ATTEMPTED TO SECURE THE LOOP TO THE PARENT VESSEL WALL BUT THIS WAS NOT SUCCESSFUL. THE PROCEDURE WAS COMPLETED BY COILING THE ANEURYSM AND THE COIL LOOP REMAINED PROTRUDING INTO THE PARENT VESSEL. THE PATIENT WAS REPORTED TO BE NEUROLOGICALLY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET COIL DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC - CORK M0035461430 14044772

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention