The following was received via email:
On 4/8/2016 a patient was being treated with Y-90 TheraSpheres. Written directive prescribed 4.15 GBq (117 mCi) Y-90 TheraSpheres to the left liver lobe. The catheter placement was confirmed by the Interventional Radiologist with an angiogram to administer the microspheres to the left liver lobe. The dose of 4.07 GBq of Y-90 TheraSpheres was administered. This patient was part of a study to image the location of the Y-90 TheraSpheres using a PET/MRI unit. The PET/MRI images were taken on 4/15/2016 and were read by a Radiation Oncology Authorized User on 4/16/2016. The PET/MRI images indicated that the majority of the microspheres were deposited in the right liver lobe. The Radiation Safety Officer (RSO) was immediately notified. Evaluation of the incident in accordance with the 'Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere and SIR-Spheres Licensing Guidance' (February 12, 2016, Revision 9) event reporting criteria was done by the RSO, Radiation Safety Committee (RSC) Chairman, Management and Radiation Oncology and the incident was judged not to be a medical event due to unintentional patient intervention. The patient and the physician were notified of the incident.
The RSO has been discussing this incident with the University's NRC Region III Lead Inspector [Gattone] over the past few weeks. The Inspector let the RSO know that NRC Headquarters and Region III had determined that the incident is a medical event. The Inspector requested on 1/30/2017 that the RSO report the medical event to the NRC Operations Center.
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.
- * * UPDATE FROM SUSAN LANGHORST (RSO) TO HOWIE CROUCH ON 2/20/17 AT 0923 EST * * *
The RSO provided some minor corrections to the organization name as well as correcting one date in the original report. The original report stated that PET/MRI images were taken on 4/15/16 when they were actually taken on 4/8/16.
Notified the R3DO (Pelke) and
NMSS (via email).