BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVALON ELITE BI-CAVAL DUAL

    MDR report key: 2842616 · Received November 9, 2012

    Report

    Report Number
    8010762-2012-00046
    Event Type
    Death
    Date Received
    November 9, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 11, 2012
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWF
    PMA / PMN Number
    K081820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE REPORTED EVENT OCCURRED WHILE INSERTING A 27FR CATHETER. THE SURGEON DID NOT HAVE THE ELITE VASCULAR ACCESS KIT AND USED AVAILABLE INTRODUCERS AND WIRE. WHILE INSERTING THE CATHETER, IT WAS DISCOVERED THE WIRE HAD COILED IN THE RIGHT ATRIUM BUT HAD NOT PERFORATED IT. THE RIGHT INTERNAL JUGULAR VEIN WAS TRANSECTED WITH THE CANNULA. IT WAS NOT REPAIRED, BUT RATHER EACH END WAS TIED OFF. THE CATHETER AND WIRE WERE REMOVED. THE PATIENT WAS FOUND TO HAVE HAD A CENTRAL NERVOUS SYSTEM HEMORRHAGE, WITH PROGRESSION TO BRAIN DEATH AND WAS TAKEN OFF ECMO. BEFORE THE PATIENT COULD BE DECLARED BRAIN DEAD THEY SUFFERED A CARDIAC ARREST FROM HYPOXIA. THE PATIENT WAS CANULATED ON (B)(6) 2012 AND DECANNULATED ON (B)(6) 2012 DUE TO CENTRAL NERVOUS SYSTEM HEMORRHAGE. THE PATIENT EXPIRED ON (B)(6) 2012. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVALON ELITE BI-CAVAL DUAL CATHETER DWF MAQUET CARDIOPULMONARY AG AVALON ELITE 27F NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death