BEUDAMED
    FDA Adverse Event Death Summary report: N

    HI-TORQUE FLOPPY II GUIDE WIRE

    MDR report key: 34783 · Received June 4, 1996

    Report

    Report Number
    34783
    Event Type
    Death
    Date Received
    June 4, 1996
    Date of Event
    May 24, 1996
    Report Date
    May 31, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED LEFT HEART CATHETERIZATION WITH LEFT VENTRICULAR ANGIOGRAM AND RIGHT AND LEFT CORONARY ANGIOGRAM, PTCA AND STENT; INITIALLY TOLERATED PROCEDURE FAIRLY WELL. PT DEVELOPED POSSIBLE TAMPONADE AFTER TRANSFER BEGAN FROM CATH LAB; EXPIRED AFTER MULTIPLE ATTEMPTS TO RESUSCITATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE FLOPPY II GUIDE WIRE GUIDEWIRE DQX ADVANCED CARDIOVASCULAR SYSTEMS, INC. UNKNOWN 6040151

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death