BEUDAMED
    FDA Adverse Event Other Summary report: N

    EMBOL-X ACCESS DEVICE / AORTIC CANNULA

    MDR report key: 496512 · Received November 14, 2003

    Report

    Report Number
    6000002-2003-00356
    Event Type
    Other
    Date Received
    November 14, 2003
    Date of Event
    October 16, 2003
    Report Date
    October 17, 2003
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY THE PATIENT WAS CANNULATED, THEN WHEN FILTER WAS DEPLOYED IT STUCK. THE DR FELT REASON FOR THE STUCK FILTER WAS THAT THE CANNULA WAS NOT TRULY SEATED AGAINST THE AORTA. THE CANNULA THEN POPPED OUT OF THE AORTA, BLEEDING OCCURRED. THE DR HAD TO CROSS CLAMP, RECANNULATE, DE-AIR AND GO BACK ON BYPASS. HOWEVER, NO PERMANENT PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMBOL-X ACCESS DEVICE / AORTIC CANNULA AORTIC PERFUSION CANNULA DWF EDWARDS LIFESCIENCES CF00101D UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention