BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AORTIC CROSS CLAMP

    MDR report key: 350407 · Received September 7, 2001

    Report

    Report Number
    1423507-2001-00228
    Event Type
    Injury
    Date Received
    September 7, 2001
    Date of Event
    August 6, 1999
    Report Date
    September 7, 2001
    Manufacturer
    ALLEGIANCE HEALTHCARE CORP.
    Product Code
    DXC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PLAINTIFF ALLEGES THAT IN 1999, DURING A CORONARY BYPASS PROCEDURE, THERE WAS A MECHANICAL DEFECT IN THE CLAMP. THE PLAINTIFF FURTHER ALLEGES THAT WHEN THE CLAMP WAS APPLIED TO THE ASCENDING AORTA, THE DEFECT PERMITTED THE CLAMP TO BE APPLIED IN AN "OVER BITE" CONFIGURATION. IN ADDITION, THE PLAINTIFF ALLEGES, THIS CAUSED AN INJURY TO THE AORTA, WHICH RESULTED IN A DISSECTING ANEURYSM OF THE AORTA, WHICH DISSECTION AND ENSUING TREATMENT AND CONSEQUENCE CAUSED THE PLAINTIFF, TO HAVE A MASSIVE STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40919 AORTIC CROSS CLAMP INSTRUMENT DXC ALLEGIANCE HEALTHCARE CORP. UNK-CLAMP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability