BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXPO DIAG

    MDR report key: 382255 · Received March 4, 2002

    Report

    Report Number
    6000093-2002-00017
    Event Type
    Death
    Date Received
    March 4, 2002
    Date of Event
    February 5, 2002
    Report Date
    February 19, 2002
    Manufacturer
    BOSTON SCIENTIFIC SCIMED
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    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 AB OCCLUSION OF THE LEFT CIRCUMFLEX CORONARY ARTERY. WHILE PT WAS BEING PREPARED FOR PTCA, ANOTHER MFR'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 MFR'S STENT WAS PLACED IN THE DISTAL LEFT CIRCUMFLEX. PT BP DROPPED TO 96/52 AND PT BECAME UNRESPONSIVE. A "CODE BLUE" WAS CALLED. PT WAS GIVEN MULTIPLE MEDCIATIONS 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 MYOCARIDAL INFARCTION. THERE WAS NO INDICATION THAT DEATH WAS RELATED TO EQUIPMENT MALFUNCTION. SAME CASE AS MFR'S REPORT 6000093-2002-00016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPO DIAG DIAGNOSTIC CATHETER DQO BOSTON SCIENTIFIC SCIMED MODEL D 6F FL4 SINGLE 4224812

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death