BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALON ELITE

    MDR report key: 1901423 · Received October 29, 2010

    Report

    Report Number
    2032228-2010-00010
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 28, 2010
    Manufacturer
    AVALON LABORATORIES LLC
    Product Code
    DWF
    PMA / PMN Number
    081820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CANNULA WAS INSERTED INTO THE IVC BY A COMBINATION OF LOCAL RIGHT INTERNAL JUGULAR CUT DOWN FOLLOWED BY FLUOROSCOPIC GUIDANCE OF THE CANNULA. THE GUIDEWIRE PASSED EFFORTLESSLY INTO THE IVC WITHOUT ANY DEVIATION WHATSOEVER. THE CANNULA ALSO PASSED EASILY INTO THE IVC AND WAS SECURED IN PLACE. THE CANNULA WAS FUNCTIONING WELL. ON THE AFTERNOON OF THE (B)(6) A CLOT DEVELOPED WITHIN THE CIRCUIT AND THIS WAS CUT OUT. A BOLUS OF HEPARIN WAS GIVEN. SHORTLY AFTER GIVING THE BOLUS OF ANTI-COAGULATION SHE DROPPED HER BLOOD PRESSURE. A BOLUS OF FLUID WAS GIVEN WITHOUT IMPROVEMENT. AN ECHO WAS PERFORMED AND THIS SHOWED A PERICARDIAL EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVALON ELITE 13 FR BI-CAVAL LUMEN CATEHTER DWF AVALON LABORATORIES LLC 13 FR AVALON ELITE 090319918596

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Life Threatening