Event Notification Report for November 18, 2019

AGREEMENT STATE REPORT - AIRCRAFT INSTRUMENT WITH RADIUM-226 PAINTED DIAL FOUND

The following information was received via E-mail:

"On 11/18/2019, Massachusetts Radiation Control Program (MARCP) was informed by Schnitzer Steel Industries, Inc., that a scrap metal shipment from Devens Recycling in Danvers, MA set off the radiation monitor alarm. The vehicle was redirected back to Devens Recycling for follow-up survey and mitigation in accordance with MA RCP DOT Special Permit MA-MA-19-10. On 11/19/2019, the material was identified and segregated from the scrap metal load by an independent radiation consultant. The radioactive material discovered was radium-226 painted on the dial of an abandoned (lost), old Aircraft Turn/Slip Coordinator instrument. The dose rate at 6 inches from the instrument was 200 microR/hr. The background dose rate was 20 microR/hour. The radiation survey instrument used to locate the source was a Ludlum Model 193-6. A Ludlum Model 9DP-1 ion chamber was used for direct measurements on the instrument. A Ludlum Model 702 Multi Channel Analyzer was used to identify the radioisotope. The radium-226 activity was estimated to be approximately 6.31 microCuries based on the dose rate measured. This material is being stored in a sealed polyethylene bag placed in a sealed 55 gallon drum and labeled as radioactive material held for disposal.

"This activity meets the 30-day event report requirement for lost or abandoned radioactive material greater than 10 times the quantities specified in 10 CFR 20 Appendix C, or the Massachusetts equivalent, 105 CMR 120.297 Appendix C, which is ten times reportable quantity for Radium-226 (1 microCurie).

"The Agency [MARCP] considers this event to be open until proper disposal of this instrument is confirmed."

Massachusetts Docket No.: 23-3968

THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL

Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf

AGREEMENT STATE REPORT - PATIENT UNDERDOSAGE OF Y-90 RESIN SIR-SPHERES

The following report was received from the Vermont Department of Health via email:

"Medical Event: Y90 resin Sir-Spheres treatment infusion aborted due to kinked microcatheter. 99.5 [percent] of the drawn dose was not delivered to the treatment site. Contamination of IR [interventional radiology] suite floor detected. Contamination of infusion paraphernalia (gloves, shoe covers, gauze, towels) detected. Contaminated items were contained and floor was decontaminated to acceptable levels by RSO [Radiation Safety Officer].

"Date of Event: 11/18/2019

"11/18/19 AU [Authorized User] notified referring physician and patient of the medical event
11/19/19 RSO contacted State of Vermont
11/19/19 NRC contacted for clarification of event
11/20/19 RSO contacted Sirtex

"Incident Details:
Terumo Progreat, I.D. 0.027[inches] (0.7mm), 130cm length, was used initially to access treatment site.
Boston Scientific, I.D. 0.021[inches] (0.5mm), 130cm length, was used to access treatment site after unsuccessful attempt with Progreat.

"IR [Interventional Radiologist] Fellow assembled the delivery device.

"The original dose measurement was 2.2 mR/hr at 1230 [EST]. The Nalgene with undelivered dose vial and the second Nalgene with delivery catheter were measured in exactly the same setup as original dose measurement. The total residual in the 2 Nalgene containers were 1.9 mR/hr + 0.25 mR/hr = 2.15 mR/hr at 1430. With 2 hours decay correction, the Nalgene containers reading should be 2.15 x 1.02 = 2.19 mR/hr.

"2.19 / 2.2 = 0.995 or 99.5 [percent] for Vial + Catheter. Therefore, about 0.5 [percent] of the drawn dose (44.3 mCi) was lost. 0.5 [percent] of 44.3 mCi is 0.2 mCi (This is the calculated amount of Y90 lost)

"The DAVYR [Dosimetry and Activity Visualizer for Y-90 Radioembolization] application provides the following liver dose calculation based on the partition model:
Liver = 27.5 Gy for a 1.5 GBq (or 40.5 mCi) dose delivery. This is based on 100 [percent] of prescribed dose being delivered.

"In the worst-case scenario where all the lost activity (0.2 mCi) was delivered to the patient, the liver dose calculation is:
Liver = 27.5 Gy x (0.2 mCi / 40.5 mCi) = 0.14 Gy (or 14 rem)

"The only way to properly measure the bags of contaminated paraphernalia (towels, gloves, gauze, shoe covers) in the same setup as the original dose measurement would involve transferring the contents into several Nalgene containers. This can be done next day to properly account for lost Y90 activity.

"Medical event criteria - the byproduct material administration has to meet the following (10 CFR 35.3045):

"1. The dose differs from a dose that would have resulted from the prescribed dosage by more than 50 rem to an organ or tissue. The unintended dose to any organ or tissue from the lost 0.2 mCi Y90 would be similar to the Liver dose calculated above (14 rem) and does not exceed 50 rem difference.
Note: The highest delivered dose to Liver from the lost Y90 is calculated to be 14 rem. This is below the target dose of 110 Gy (or 11,000 rem) and does exceed the 50 rem difference; however, this was a medical safety decision resulting from unforeseen microcatheter kinking due to patient anatomy.

"2. The total dose delivered differs from the prescribed dose by 20 [percent] or more. Yes, the total dose delivered is calculated to be about 0.2 mCi and is much below the prescribed dose of 40.5 mCi. A medical safety decision to abort the infusion was due to an unforeseen device event (kinked microcatheter) that prevented the safe delivery of Y90 microspheres."

* * * UPDATE ON 11/26/19 AT 0738 EST FROM FRANCIS ONEILL TO OSSY FONT * * *

The following update was received from the Vermont Department of Health via email:

"As a follow up to Event Number 54408, Y-90 Sirsphere event, the calculated dose to the unintended organ, the pancreas, is 14 Rem or 0.14 Gray."

Notified R1DO (Henrion) and NMSS Events Notification via email.

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.