BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRESSURE WIRE SENSOR

    MDR report key: 514500 · Received February 27, 2004

    Report

    Report Number
    8030904-2004-00001
    Event Type
    Death
    Date Received
    February 27, 2004
    Date of Event
    February 5, 2004
    Report Date
    February 27, 2004
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN THE CONTEXT OF AN ANGIOPLASTY OF A PT WITH A STENOSIS OF BOTH THE LEFT MAIN AND CORONARY CIRCUMFLEX ARTERY, THE PRESSUREWIRE SENSOR (PW) WAS USED FOR FRACTIONAL FLOW RESERVE (FFR) ASSESSMENTS TO GAIN MORE INFO ABOUT THE SEVERITY OF THE LESIONS. AFTER A DECISION WAS MADE TO TREAT THE CIRCUMFLEX LESION, A BALLOON CATHETER WAS ADVANCED OVER THE PW TO DELIVER TREATMENT OF THIS PARTICULAR STENOSIS, RESULTING IN THE THREE CONSECUTIVE INFLATIONS. AFTER REMOVAL OF THE BALLOON CATHETER AN ANGIOGRAM WAS PERFORMED INDICATING A SPIRAL DISSECTION OF THE MID CIRCUMFLEX ARTERY. IN AN ATTEMPT TO TREAT THE SPIRAL DISSECTION, A MULTI-LINK ZETA STENT (3.0X38MM) WAS ADVNACED OVER THE PW. WHEN ADVANCING THE STENT IN THE CIRCUMFLEX ARTERY, A RESISTANCE WAS NOTED AND THE STENT COULD NOT BE FURTHER ADVANCED AND DELIVERED. A GUIDE WIRE (BMW) WAS INTRODUCED TO HELP REMOVE THE STENT AND PW AS A SINGLE UNIT. A REPEATED ANGIOGRAM SHOWED THAT THE DISSECTION HAD TRAVELLED UP TO INCLUDE THE LEFT MAIN ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE WIRE SENSOR GUIDEWIRE SENSOR DQX RADI MEDICAL SYSTEMS AB 12004 030784

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death GUIDEWIRE.| GUIDANT MULTI-LINK ZETA STENT, GUIDANT BMW| GUIDANT CROSS SAIL BALLOON DILATATION CATHETER,