The following information was received from the Commonwealth of
Pennsylvania via facsimile:
Event Type: A medical event (ME) involving Y-90 Theraspheres where the patient received 51% of the intended dose, which is reportable under 10CFR35.3045(a)(1)(ii).
'Notifications: On September 16, 2011, at 1414 [EDT], the Department's Southeast Regional Office received notification via phone message about the ME.
Event Description. The patient was being treated with MDS Nordion Y-90 glass Theraspheres for transarterial radioembolization. A suspected defective catheter caused 49% of the intended dose to clog up in the catheter. No harm to the patient is expected. The referring physician and patient have been notified. No more information is available at this time.
Cause of the event: The cause of the event is suspected to be a defective catheter.
Actions: After decay, the catheter will be returned to Nordion for inspection and may also be returned to the manufacturer, Terumo Medical, for a defect analysis. The licensee will be submitting a written report within 15 days. The [Pennsylvania] Department [of Environmental Protection] plans to do a reactive inspection.
PA Report ID: PA110025
A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.