BEUDAMED
    FDA Adverse Event Death Summary report: N

    3-WAY MANIFOLD

    MDR report key: 10309 · Received October 18, 1993

    Report

    Report Number
    10309
    Event Type
    Death
    Date Received
    October 18, 1993
    Date of Event
    August 11, 1993
    Report Date
    October 12, 1993
    Manufacturer
    PROCEDURE PRODUCTS
    Product Code
    DTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT TRANSFERRED HERE FOR EMERGENT CARDIAC CATHETERIZATION AND PLACEMENT OF TEMPORARY TRANSVENOUS PACEMAKER. PRESUMPTIVE DIAGNOSIS: ACUTE INFERIOR MYOCARDIAL INFARCTION COMPLICATED BY COMPLETE HEART BLOCK AND HYPOTENSION. AT TIME OF TRANSFER PT WAS EXPERIENCING CHEST PAIN. UPON ARRIVAL PT WAS AWAKE AND ALMOST FREE OF CHEST PAIN. BP WAS 110/64 HR 91. A DIAGNOSITC 8 FR JR4 CATHETER WAS PLACED IN THE ASCENDING AORTA WITHOUT ENGAGEMENT TO OBTAIN CINEANGIOGRAPHIC VIEWS, UTILIZING OMNIPAQUE NON-IONIC CONTRAST SOLUTION. APPROX 150 CC WERE UTILIZED IN LOCALIZING THE ARTERY, CLEARING CATHETER AND OBTAINING THE ANGIOGRAMS. A SECOND 150 CC BOTTLE OF OMNIPAQUE CONTRAST WAS CONNECTED TO MANIFOLD TUBING AND ANY AIR WITHIN THE LINE WAS CLEARED. THE DIAGNOSTIC RIGHT CATH WAS EXCHANGED OVER A WIRE FOR AN 8 FR JUDKINS LEFT 4 GUIDE CATHETER, WITH WHICH THE LEFT CORONARY OSTIUM WAS ENGAGED. MD WAS MANIPULATING THE CATHETER AND PERFORMING HAND INJECTIONS OF CONTRAST. TWO CINEANGIOGRAPHIC VIEWS WERE OBTAINED REVEALING CRITICAL CORONARY STENOSIS ONLY OF THE DOMINANT CIRICUMFLEX BRANCH. THROMBUS WAS NOTED. AN ADD'L AGNULATED VIEW WAS THEN SET UP, UTILIZING SMALL HAND INJECTIONS OF SEVERAL MILLILITERS OF CONTRAST TO VISUALIZE THE ARTERY WHILE THE PICTURE WAS FRAMED AND ANGLES ADJUSTED. AT THIS POINT A QUANTITY OF AIR WAS INJECTED INTO THE LEFT MAIN CORONARY AND BUBBLES OF AIR WERE VISUALIZED TRAVELING OUT THE LEFT ANTERIOR DESCENDING AND CIRCUMFLEX BRANCHES. MANIFOLD SYSTEM AND IN-LINE TUBING LEADING FROM THE BOTTLE OF CONTRAST, AT ITS CONNECTION WITH THE TOP OF THE 3-WAY MANIFOLD (LUER-LOCK CONNECTION) WAS FOUND TO HAVE LOOSENED, ALLOWING AIR TO BE ASPIRATED INTO THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3-WAY MANIFOLD DTL PROCEDURE PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death