BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXPO DIAG

    MDR report key: 380198 · Received March 4, 2002

    Report

    Report Number
    6000093-2002-00016
    Event Type
    Death
    Date Received
    March 4, 2002
    Date of Event
    February 5, 2002
    Report Date
    February 19, 2002
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED PER MEDWATCH THAT THE PT WAS UNDERGOING DIAGNOSTIC ANGIOGRAPHY WITH POSSIBLE PTCA. PT WAS ADMITTED TO THE CATH LAB ALERT, ORIENTED AND PAIN FREE. BP WAS 177/93, PULSE WAS 110. PT WAS FOUND TO HAVE AN OCCLUSION OF THE LEFT CIRCUMFLEX CORONARY ARTERY. WHILE PT WAS BEING PREPARED FOR PTCA, ANOTHER MANUFACTURER'S CORONARY GUIDE CATHETER WAS INSERTED INTO THE LEFT MAIN. PT BEGAN TO COMPLAIN OF CHEST AND BACK PAIN AND WAS TREATED WITH DILAUDID AND VERSED. ANOTHER MANUFACTURER'S STENT WAS PLACED IN THE DISTAL LEFT CIRCUMFLEX. PT'S BP DROPPED TO 96/52 AND PT BECAME UNRESPONSIVE. A "CODE BLUE" WAS CALLED. PT WAS GIVEN MULTIPLE MEDICATIONS INCLUDING HEPARIN, DOPAMINE, EPINEPHRINE, LIDOCAINE, SODIUM BICARBONATE, ATROPINE AND LEVOPHED. PT WAS INTUBATED ON THE THIRD ATTEMPT AND DEFIBRILLATED SEVERAL TIMES DURING RESUSCITATION EFFORTS. THE CAUSE OF DEATH WAS LISTED AS SUDDEN OCCLUSION OF THE LEFT MAIN STEM ARTERY AND MYOCARDIAL INFARCTION. THERE WAS NO INDICATION THAT DEATH WAS RELATED TO EQUIPMENT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPO DIAG DIAGNOSTIC CATHETER DQO BOSTON SCIENTIFIC CORP MODEL D 6F FR4 SINGLE 102544

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death