BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYROCOIL EMBOLIC SYSTEM (HES)

    MDR report key: 865126 · Received September 22, 2006

    Report

    Report Number
    2032493-2006-00008
    Event Type
    Other
    Date Received
    September 22, 2006
    Date of Event
    August 25, 2006
    Report Date
    August 25, 2006
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE 0.5 CM OF COIL REMAINING IN THE PARENT ARTERY. AS A PREVENTIVE ACTION, PHYSICIANS ARE BEING RE-TRAINED REGARDING THE COMPATIBLE MICRO-CATHETERS TO BE USED AS LISTED IN THE DEVICE INSTRUCTIONS FOR USE. AN ANALYSIS OF THE HES DELIVERY PUSHER INDICATED DAMAGE TO THE HEATER COIL USED TO DETACH THE COIL. THIS DAMAGE CAUSED THE DIFFICULTY EXPERIENCED IN DETACHING THE COIL. A SUMMARY OF THE CORRECTIVE ACTIONS IMPLEMENTED TO PREVENT DAMAGE TO THE HEATER COIL IS ATTACHED.

    Description of Event or Problem · 1

    AN HES-18 16-MM X 20-CM EMBOLIZATION COIL WAS BEING DEPLOYED THROUGH AN EXCELSIOR 1018 ACCESSORY MICRO-CATHETER. THIS MICRO-CATHETER IS NOT COMPATIBLE WITH THE HES-18 COILS PER THE PRODUCT LABELING. THE INNER DIAMETER OF THIS MICRO-CATHETER IS 0.019 INCH. A MICRO-CATHETER WITH A MINIMUM INNER DIAMETER OF 0.021 INCH MUST BE USED. DURING DEPLOYMENT, THE PHYSICIAN EXPERIENCED DIFFICULTY DETACHING THE COIL. IN THIS SITUATION, THE COIL IS REMOVED. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL, IT BECAME STUCK IN THE MICRO-CATHETER SINCE THE HES POLYMER MATERIAL HAD BEGUN TO EXPAND AND THE INNER DIAMETER OF THE MICRO-CATHETER WAS NOT LARGE ENOUGH TO ALLOW REMOVAL. THE COIL DID DETACH WITH SOME MANIPULATION. HOWEVER, APPROXIMATELY 0.5CM OF THE COIL REMAINED IN THE PARENT ARTERY. THE REMAINING 19.5 CM OF THE COIL WAS DEPLOYED INTO THE ANEURYSM AS INTENDED. NO PATIENT INJURY RESULTED DUE TO THE 0.5CM OF COIL IN THE PARENT ARTERY AND NO INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYROCOIL EMBOLIC SYSTEM (HES) EMBOLIZATION COIL HCG MICROVENTION, INC. 181620HES-V P0606133

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other