BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL DURAL SEALANT SYSTEM OUS

    MDR report key: 1233945 · Received November 14, 2008

    Report

    Report Number
    3003157248-2008-00024
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    August 27, 2008
    Report Date
    October 14, 2008
    Manufacturer
    CONFLUENT
    Product Code
    NQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DURASEAL WAS APPLIED TO THE SURGICAL SITE USING A MICROMYST APPLICATOR CONNECTED TO A CONFLUENT SURGICAL FLOW REGULATOR. USING THE AVAILABLE INFORMATION FROM LITERATURE, AND FROM DISCUSSIONS WITH NEUROSURGEONS, WE HAVE CONCLUDED THAT ANY CONNECTION BETWEEN THE USE OF DURASEAL WITH THE MICROMYST APPLICATOR AND CARDIAC ARREST IS UNLIKELY. THIS IS FOR THE FOLLOWING REASONS. THE FLOW OF BLOOD THROUGH THE CAROTID ARTERIES IS TOWARD THE BRAIN AND NOT THE HEART. THE PRESSURE WITHIN THE CAROTID ARTERIES IS MUCH GREATER THAN WHICH COULD BE EXERTED BY THE MICROMYST APPLICATOR (EITHER BY PRESSURE OR MANIPULATION). THERE ARE MANY OTHER SOURCES OF STRESS ON THE CAROTID ARTERIES THAT DO NOT RESULT IN CARDIAC ARREST. THE PROBABILITY OF AIR EMBOLISM MIGRATING FROM AN OPEN VEIN (A.K.A. "BLEEDER") WITHIN THE SINUS CAVITY TO THE HEART CAUSING CARDIAC ARREST IS REMOTE. THE LITERATURE CONTAINS REFERENCES TO PATIENTS WHO HAVE EXPERIENCED CARDIAC ARREST AFTER TRANSSPHENOIDAL RESECTION OF A PITUITARY ADENOMA THAT DID NOT INVOLVE USE OF THE DURASEAL PRODUCT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, AFTER UNEVENTFUL REMOVAL OF PITUITARY ADENOMA VIA TNS APPROACH, DURING RECONSTRUCTION OF THE SELLA FLOOR WITH AUTOLOGOUS FAT, AN EPISODE OF CARDIAC ARREST (ASYSTOLE) OCCURRED REQUIRING CPR RESUSCITATION. THE ADVERSE EVENT OCCURRED WHILE SPRAYING DURASEAL (USING MICROMYST APPLICATOR CONNECTED TO A CONFLUENT SURGICAL FLOW REGULATOR) OVER THE BONE AND THE DURAL DEFECT. CPR RESUSCITATION WAS SUCCESSFUL AND NORMAL HEART RHYTHM WAS IMMEDIATELY REPRISTINATED. PATIENT RECOVERED WELL FROM ANESTHESIA WITHOUT ANY SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASEAL DURAL SEALANT SYSTEM OUS DURAL SEALANT NQR NQR CONFLUENT C031981-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R