BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOGRAPHIC CATHETER

    MDR report key: 379899 · Received February 15, 2002

    Report

    Report Number
    379899
    Event Type
    Death
    Date Received
    February 15, 2002
    Date of Event
    February 5, 2002
    Report Date
    February 15, 2002
    Manufacturer
    BOSTON SCIENTIFIC SCIMED INC
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ARRIVED IN THE CATH LAB FOR LEFT HEART CATH WITH POSSIBLE PTCA AT 1504. PT WAS ALERT AND ORIENTED, PAIN FREE WITH VITAL SIGNS 177/93 PULSE 110. BLOOD PRESSURE RANGING FROM 177/93 TO 149/90 UNTIL 1538. HEART CATH PROCEDURE BEGAN AND AT 1529 A 6.5 FR. SHEATH WAS INTRODUCED INTO THE ARTERY. PHYSICIAN OBSERVED AN OCCLUSION OF THE LEFT CIRCUMFLEX CORONARY ARTERY. PROCEEDED TO PREPARE FOR PTCA. AT 1538 PT BEGAN TO COMPLAIN OF BACK PAIN. PT MEDICATED FOR PAIN WITH DILAUDID 1 MGM IVP. WHILE MEDICATION BEING ADMINISTERED THE LEFT CORONARY GUIDE CATHETER WAS INTRODUCED INTO THE LEFT MAIN AND THE PT BEGAN TO COMPLAIN OF CHEST PAIN. THE PT IMMEDIATELY BECAME SYMPTOMATIC, WITH B/P DROPPING 96/52. THE PT BECAME UNRESPONSIVE AND A "CODE BLUE/MEDIC" WAS CALLED. MULTIPLE MEDICATIONS INCLUDING EPINEPHRINE 1 MGM TIME 3, SODIUM BICARBORATE 1 AMP, ATROPINE 1 MGM TIMES 2, LIDOCAINE 100 MGM IVP, LIDOCAINE DRIP AND LEVOPHED DRIP WERE ADMINISTERED. DEATH WAS PRONOUNCED AT 1644. CAUSE OF DEATH LISTED AS SUDDEN OCCLUSION OF LEFT MAIN STEM ARTERY AND MYOCARDIAL INFARCTION. ALL MEDICAL EQUIPMENT IN USE HAS BEEN SENT TO MFR FOR EVALUATION. NO INDICATION THIS PT'S DEATH IS RELATED TO EQUIPMENT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGRAPHIC CATHETER 6 FR FL4 ANGIOGRAPHIC CATHETER DQO BOSTON SCIENTIFIC SCIMED INC * 102544
    2 ANGIOGRAPHIC CATHETER 6 FR FR4 ANGIOGRAPHIC CATHETER DQO BOSTON SCIENTIFIC SCIMED, INC * 4224812
    3 ACS HI-TORQUE, BALANCE HEAVYWEIGHT GUIDE WIRE BHW J 190CM .0 GUIDE WIRE DQX ADVANCED CARDIOVASCULAR SYSTEMS, INC * 2012152
    4 3.5 MM/13 MM PENTA STENT STENT MAF MEDTRONIC AVE * *
    5 ZUMA JL4.0 4.0 JL 6 FR. GUIDE DYB MEDTRONIC AVE * 101357
    6 VECTOR X 4.0 JL MEDTRONIC 6 FR DYB MEDTRONIC * 101777

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death