BEUDAMED
    FDA Adverse Event Death Summary report: N

    RADI PRESSUREWIRE 4

    MDR report key: 514228 · Received March 1, 2004

    Report

    Report Number
    514228
    Event Type
    Death
    Date Received
    March 1, 2004
    Date of Event
    February 5, 2004
    Report Date
    February 27, 2004
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    NQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT. UNDERGOING EMERGENT CARDIAC CATHETERIZATION. FINDINGS INCLUDED 40-50% STENOSIS OF LEFT MAIN CORONARY ARTERY (LMCA) AT ORIGIN AND 80% STENOSIS OF THE MIDPORTION OF THE CIRCUMFLEX ARTERY (CCX). AS CCX WAS FELT TO BE CAUSE OF SYMPTOMS, FFR MEASUREMENTS WERE TAKEN. INSTRUMENTATION AS LISTED BELOW. THERE WAS A SUBSTANTIAL GRADIENT ACROSS THE CCX LESION AND A DECISION MADE TO STENT THE LESION. ATTEMPTS TO PLACE THE STENT COULD NOT PASS BEYOND THE MIDPORTION OF THE LESION. ON ATTEMPTING TO PULL STENT BACK INTO THE GUIDING CATHETER, THERE WAS RESISTANCE. WITH SOME PULLING, THE STENT WAS PULLED ABOUT 20 CM. BACK INTO THE GUIDING CATHETER OVER THE RADI WIRE BUT COULD NOT BE RETRIEVED FURTHER. AFTER INSERTING A NEW BMW WIRE THROUGH THE GUIDING CATHETER ADJACENT TO THE RADI WIRE, AND ADVANCING IT PAST THE CCX LESION, THE RADI WIRE AND STENT WERE REMOVED AS A UNIT. JUST AFTER THIS, BLOOD PRESSURE DROPPED AND HEART RATE SLOWED. INJECTION TO LMCA REVEALED TOTAL LMCA OCCLUSION. FROM THIS POINT, PATIENT DETERIORATED, LMCA FLOW COULD NOT BE REESTABLISHED, AND RESUSCITATION FAILED AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADI PRESSUREWIRE 4 0.014 GUIDEWIRE MOUNTED PRESSURE SENSOR NQH RADI MEDICAL SYSTEMS AB * 030784
    2 MULTI-LINK ZETA CORONARY STENT SYSTEM STENT, 3.0MM X 38MM MAF GUIDANT CORP * *
    3 VIKING GUIDING CATHETER GUIDING CATHETER JL4, 6F, 0.66" ID DYB GUIDANT/VASCULAR INTERVENTION JL4 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death