BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACS HI-TORQUE EXTRA SUPPORT GUIDE WIRE

    MDR report key: 40306 · Received September 26, 1996

    Report

    Report Number
    2024168-1996-00008
    Event Type
    Death
    Date Received
    September 26, 1996
    Date of Event
    March 19, 1996
    Report Date
    September 26, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PTCA/STENT PROCEDURE OF A LEFT CIRCUMFLEX LESION, THE GUIDEWIRE TIP FRACTURED. AT THIS TIME, THE PHYSICIAN NOTED DYE EXTRAVASATION BUT DID NOT UNDERSTAND WHAT HAD OCCURRED. AFTER SOME DIFFICULTY WITH MOVEMENT, THE DR WAS ABLE TO DEPLOY THE STENT SUCCESSFULLY. UPON REMOVAL OF THE GUIDEWIRE FROM THE PT, IT WAS NOTED THAT A PERFORATION OF THE VESSEL HAD OCCURRED. THE PT EXPERIENCED CARDIAC TAMPONADE AND A PERICARDIAL TAP WAS PERFORMED. THE PT EXPIRED A FEW MINS LATER. THE DR HAD INDICATED THAT THE GUIDE WIRE WAS SUBJECTED TO SEVERAL PRESSURES BEFORE THE DEPLOYMENT OF THE STENT WHICH COULD HAVE EXPLAINED WHY THE TIP OF THE GUIDE WIRE FRACTURED. PHYSICIAN ALSO INDICATED THAT THE 90-YR-OLD PT MAY HAVE HAD FRAIL ARTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE EXTRA SUPPORT GUIDE WIRE GUIDE WIRE DQX ADVANCED CARDIOVASCULAR SYSTEMS, INC. NA 6012251

    Patients

    Seq Age Sex Outcome Treatment
    1 90 * Death