Description of Event or Problem · 1
SIRTEX 2.8 FRENCH MICRO CATHETER USED IN NUCLEAR MEDICINE WAS OCCLUDED AND DRUG COULD NOT BE DELIVERED IN FULL. A PATIENT WAS PRESCRIBED A DOSE OF 3 GBQ RECEIVED APPROXIMATELY 0.7 GBQ Y-90 MICROSPHERES (SIRTEX SIR-SPHERES) FOR THE TREATMENT OF CANCER IN THE LEFT LOBE OF THE LIVER. BASED ON THE RESIDUAL ACTIVITY MEASURED AT THE COMPLETION OF THE TREATMENT, THE PATIENT MAY HAVE RECEIVED 20 - 23% OF THE PRESCRIBED DOSE. INSTEAD OF THE INTENDED ABSORBED DOSE OF 63 GY TO THE LEFT LOBE OF THE LIVER, THE PATIENT RECEIVED LESS THAN 14.8 GY. THE MOST LIKELY ROOT CAUSE OF THE OCCLUSION WAS THAT A RELATIVELY HIGH CONCENTRATION OF Y-90 SIR-SPHERES OCCLUDED THE LUMEN OF THE SIRTEX MICRO-CATHETER. THE AU (AUTHORIZED USER) TERMINATED THE THERAPY ADMINISTRATION BECAUSE AN OCCLUSION IN THE MICRO-CATHETER PREVENTED THE DELIVERY OF THE MICROSPHERES TO THE TREATMENT SITE. AN INCIDENT REPORT WAS FILED BY SIRTEX, THE Y-90 MICROSPHERE MANUFACTURER, SEVERAL DAYS AFTER THE EVENT. ONCE ADEQUATE DECAY IN STORAGE HAS OCCURRED (ESTIMATED 60 DAYS), THE Y-90 DELIVERY SET AND SHIPPING VIAL USED IN THIS MEDICAL EVENT WILL BE RETURNED TO THE MANUFACTURER (SIRTEX) FOR ANALYSIS. FULL DECAY TIME IS ESTIMATED TO BE 60 DAYS. ONCE RECEIVED BY SIRTEX, THE ANALYSIS TAKES ABOUT 2 WEEKS. THIS EVENT WAS REPORTED TO THE U.S. NRC OPERATIONS CENTER. NO ADVERSE EFFECTS ON THE PATIENT ARE EXPECTED FROM THIS UNDER DOSE. THE PATIENT WAS SUBSEQUENTLY SUCCESSFULLY TREATED WITH COMPENSATING DOSE ACTIVITY OF 2.6 GBQ OF Y-90 MICROSPHERES TO LEFT LOBE OF THE LIVER.