BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUARDWIRE PLUS 2-5RX-6F

    MDR report key: 620222 · Received July 8, 2005

    Report

    Report Number
    1220452-2005-00075
    Event Type
    Death
    Date Received
    July 8, 2005
    Date of Event
    June 21, 2005
    Report Date
    June 21, 2005
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED, HOWEVER DURING THE PROCEDURE THE PT PASSED AWAY, DUE TO ANY MALFUNCTION OR FAULT OF THE DEVICE. THE PHYSICIAN INSERTED THE OCCLUSION BALLOON WIRE INTO THE PT'S BYPASS TO THE DISTAL CIRCUMFLEX VESSEL. THE PHYSICIAN INFLATED THE OCCLUSION BALLOON TO 3.5MM TO OCCLUDE THE VESSEL. THE PHYSICIAN INSERTED THE STENT DELIVERY CATHETER AND SUCCESSFULLY PLACED THE STENT. THE PHYSICIAN REMOVED THE STENT DELIVERY CATHETER AND DEFLATED THE OCCLUSSION BALLOON. THE PHYSICIAN PULLED THE OCCLUSION BALLOON BACK INTO THE TIP OF THE GUIDE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDWIRE PLUS 2-5RX-6F DISTAL PROTECTION DEVICE NFA MEDTRONIC, INC. NA 0000036518

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death