BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD DIALYSIS CATHETER

    MDR report key: 493298 · Received October 31, 2003

    Report

    Report Number
    493298
    Event Type
    Death
    Date Received
    October 31, 2003
    Date of Event
    October 10, 2003
    Report Date
    October 20, 2003
    Manufacturer
    BARD ACCESS SYSTEM
    Product Code
    LFJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TO O.R. FOR PLACEMENT OF SUBCLAVIAN VEIN HEMODIALYSIS CATHETER. TWO ATTEMPTS MET WITH RESISTANCE. INTRAOPERATIVE VENOGRAM SHOWED STRICTURE IN THE SUPERIOR VENA CAVA BEFORE IT ENTERED RIGHT ATRIUM. SURGEON ATTEMPTED TO NAVIGATE WIRE THROUGH STRICTURE UNDER FLUOROSCOPY WHEN PT DEVELOPED SIGNS AND SYMPTOMS OF RESPIRATORY DISTRESS AND HYPOTENSION. ACLS STARTED. PROCEDURE TERMINATED. PT. UNDERWENT EMERGENCY OPEN HEART SURGERY TO RELIEVE CARDIAC TAMPONADE, REPAIR RIGHT PULMONARY ARTERY, REPAIR SVC. PRONOUNCED BRAIN DEAD THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD DIALYSIS CATHETER DIALYSIS CATHETER DILATOR LFJ BARD ACCESS SYSTEM PART# OFK23PCV2 22DL5493

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death