GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE

Description of Event or Problem

THE GUIDANT CLINICAL CONSULTANT REPORTED THAT A PRODUCT MALFUNCTION OCCURRED DURING TREATMENT OF THE THIRD OF 3 PTS. THE PREVIOUS 2 TREATMENTS WERE SUCCESSFUL. THE TREATMENT OF THE THIRD PT BEGAN WITH SUCCESSFUL POSITIONING OF THE INACTIVE WIRE. THE ACTIVE WIRE WAS DEPLOYED AND THEN STOPPED, AND THE RULER ON THE DISPLAY SCREEN INDICATED IT TO BE NEAR THE TARGET POSITION. IT WAS NOTED THAT THE YELLOW RADIATION LIGHT ON THE TOP OF THE SDU CONTINUED TO FLASH (INDICATING WIRE IN TRANSIT). A FLUORO VIEW TO CHECK THE POSITION OF THE WIRE FOUND NO SOURCE IN THE FIELD OF VIEW. A MALFUNCTION WAS SUSPECTED AND EMERGENCY PROCEDURES WERE INITIATED. THE PT WAS SURVEYED CONFIRMING THAT THE SOURCE STOPPED INSIDE THE PT. ATTEMPTS TO RETRACT THE WIRE USING THE "INTERRUPT TREATMENT" BUTTON ON THE DISPLAY SCREEN, THE RED "STOP" BUTTON ON THE UNIT, CATHETER KEY EJECTION, AND THE MANUAL RETRACT WHEEL WERE UNSUCCESSFUL. THE RADIATION ONCOLOGIST USED TONGS TO REMOVE THE CATHETER AND ACTIVE WIRE FROM THE PT. THE UNIT WAS UNPLUGGED, THUS ENGAGING THE BATTERY POWERED EMERGENCY RETRACT MOTOR, AND THE ACTIVE WIRE RETRACTED. THE PHYSICIST STATED THAT THE ACTIVE WIRE DWELLED IN THE PT FOR APPROX 60-90 SECONDS. AFTER THE CASE, THE SITE EXTENDED AND RETRACTED BOTH WIRES AND THE SYSTEM FUNCTIONED PROPERLY.