BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEGIS CATHETER

    MDR report key: 450038 · Received March 17, 2003

    Report

    Report Number
    2954753-2003-00001
    Event Type
    Injury
    Date Received
    March 17, 2003
    Date of Event
    February 11, 2003
    Report Date
    March 17, 2003
    Manufacturer
    CARDEON CORP
    Product Code
    DWF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT CABG OF FOUR VESSELS. AORTIC CANNULATION AND CABG PROCEDURE WERE UNEVENTFUL; ACTUAL DEVICE USED WAS NOT RETURNED. PT AWOKE POST-OP MOVING ALL EXTREMITIES. POST-OP COMPLICATION DEVELOPED ON POST-OP DAY ONE (POD1). ON POD1, PT WAS DIAGNOSED WITH ISCHEMIC GASTRITIS WITH A DECLINE IN RENAL FUNCTION. ON POD2 PT HAD NO URINE OUTPUT AND ELEVATED LIVER ENZYMES. USING TEE, PT WAS DIAGNOSED WITH AN AORTIC DISSECTION SECONDARY TO DISTAL CANNULATION OF A SMALL, TIGHTLY CURVED AORTA AND FRIABLE AORTIC WALL. ON POD8, THE PT WAS CRITICAL BUT STABLE REQUIRING ACUTE DIALYSIS. ON POD 15 THE PT WAS EXTUBATED. THEY WERE ENCEPHALOPATHIC AND IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEGIS CATHETER ARTERIAL RETURN CATHETER DWF CARDEON CORP 1000428 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R| S DEVICE IS USED ADJUNCTIVE TO CARDIOPULMONARY| (PROCEDURE DATES: 2003).| BYPASS (CPB), TEE USED FOR DEVICE PLACEMENT