Event Notification Report for February 13, 2019

AGREEMENT STATE REPORT - ADMINISTERED DOSE TO UNINTENDED ORGANS RESULTS OR WILL RESULT IN UNINTENDED PERMANENT DAMAGE

The following was received from the Pennsylvania Department of Environmental Protection (DEP) Bureau of Radiation Protection via email:

"On February 13, 2019, the patient was prescribed 31.3 milliCuries (mCi) Yttrium-90 (Y-90) Sirsphere for metastatic colorectal cancer and 31.69 mCi was delivered at time of treatment. From the post Y-90 Bremsstrahlung scan, performed on the day of treatment, it was discovered by the nuclear medicine physician, that some of the Y-90 microspheres also traveled to the stomach and left lobe of liver. The doctor has informed the patient and the patient is being monitored for potential complications. The doctor is working to determine the percentage of the Y-90 that went to stomach and left lobe of liver. No more information is available at this time from the licensee. The DEP will update this event as soon as more information is provided.

"The DEP will perform a reactive inspection."

The licensee reported this to the state per 10 CFR 35.3045 (b).

Pennsylvania Report: PA190004

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.

AGREEMENT STATE REPORT - REPORT OF LOSS OF BRACHYTHERAPY SEEDS

The following was received from the State of Illinois via e-mail:

"The agency [Illinois Emergency Management Agency] was notified the morning of 2/13/19 by Bard Brachytherapy, IL-02062-01, in Carol Stream to advise that a package of (34) I-125 brachytherapy seeds arrived with no obvious damage, but (5) of the (34) seeds were unaccounted for. Facility staff were immediately alerted of the issue when [the common carrier] opened the dock door and meters alerted to elevated radiation readings. (2) seeds were identified by the licensee staff outside of the package on the floor. Package wipes were taken and there is no indication of removable contamination. Each of the seeds has a current activity of 0.346 mCi and would have an exposure rate of approximately 0.6 mR/h at one foot. There is currently no reason to suspect any malicious intent or deliberate diversion of package contents. The five unaccounted for seeds contain an aggregate activity of 1.73 microCuries as of 2/13/19.

"The [common carrier] driver's vehicle was surveyed by licensee staff. Additionally, it was determined that the driver picked the package up at O'Hare airport, went to the [common carrier's] hub and then directly to Bard. Licensee staff are coordinating with [the common carrier] and are currently en route to the hub to perform surveys. Additional details will be provided as they become available. This matter remains open."

Illinois Item Number: IL190008

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 - UNDERDOSAGE TO PATIENT DURING I-131 TREATMENT

The following was received from the state of Pennsylvania:

"On 2/13/19, a patient was administered 171 milliCuries (mCi) of liquid iodine 131 (I-131) through a feeding tube inserted into the patient's gastric tube as he was unable to swallow I-131 in pill form. While flushing the feeding tube with saline, a technologist noticed a pool of liquid next to the patient on a disposable drape, on the patient, and on the imaging table, that was determined to be radioactive. The feeding tube was removed from the gastric tube, and flushed, without any further leaking. All non-essential personnel were cleared from the room and the nuclear medicine staff contained the spill, decontaminated the patient and the site. All radioactive trash was contained in a lead-lined storage drum and secured. No hospital personnel were contaminated during this event. The licensee reported that given the I-131 dose was diluted with saline, the total amount of I-131 that was spilled could not be determined at the time of the event. In an effort to determine the activity and dose the licensee surveyed all contaminated items in their storage drum. Using this data and conservative decay calculations the licensee estimates 97.2 mCi was spilled. This resulted in an under-dose of 56.8 percent. The patient is scheduled for another administration to complete the therapy. The DEP [Pennsylvania Department of Environmental Protection, Bureau of Radiation Protection] will update this event as soon as more information is provided."

Pennsylvania Event Report Number: PA190007


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.

AGREEMENT STATE REPORT - DOSE DELIVERED WAS LESS THAN PRESCRIBED

The following was received from the Arkansas Department of Health, Radiation Control Program (the Department) via email:

"The treatment prescribed activity was for 0.54 GBq (14.5 mCi) on February 13, 2019. The calibrated activity at projected treatment time was 0.53 GBq (14.3 mCi). The patient received a dose of 0.204 GBq (5.51 mCi) due to 61.5 percent of the dose remaining in the connector of the manufacturer tubing and the catheter Terumo-Progreat Microcatheter (2.0 French Catheter). The Department performed an on-site review and investigation on February 15, 2019 at approximately 1215 [CST].

"The Department performed exposure surveys of the connector confirming activity stuck at the connector site. The connector site read the highest and in that concentrated area, reading 430 mR/hr, on February 15, 2019, at approximately 1415 [CST].

"There were no spills and/or contamination during this event.

"The licensee notified the manufacturer and the manufacturer will be performing an investigation on the tubing and radiopharmaceutical/sealed sources. The licensee is continuing to investigate the root cause and is preparing an initial fifteen day written report.

"The Department is waiting on information from the manufacturer(s) and licensee for further investigation. The Department will update this report when the licensee provides additional information."

Arkansas Event AR-2019-001

* * * UPDATE AT 1516 EST ON 3/7/19 FROM ANGIE HALL TO JEFF HERRERA * * *

The following update was received from the Arkansas Department of Health, Radioactive Materials Program via email:

"The Department [Arkansas Department of Health] received a Y-90 TheraSphere Glass Microsphere patient therapy misadministration notification on February 14, 2019 from a medical licensee. The Department performed an on-site review and investigation on February 15, 2019 at approximately 1215 [CST]. The Department has received the required initial fifteen day report from the Licensee.

"The Y-90 TheraSphere therapy prescribed activity was for 0.54 GBq (14.6 mCi) on February 13, 2019. The Y-90 TheraSphere calibrated activity at projected treatment time was 0.53 GBq (14.3 mCi). The patient received a dose of 0.204 GBq (5.51 mCi) due to 61.5 percent of the dose remaining in the connector of the manufacturer tubing and the catheter. The catheter used was a Terumo-Progreat Microcatheter (2.0 French Catheter). This dose resulted in a 54.34 Gy exposure instead of the intended 143 Gy exposure.

"The Licensee performs Y-90 TheraSphere therapies on a regular basis. The Licensee's physician/Authorized User and colleagues state that they have never had this issue before. The Authorized User states that 54.34 Gy is still a therapeutic dose. A patient CT follow-up scan will be performed to evaluate the therapy dose effectiveness.

"The Department verified activity stuck at the connector site via exposure surveys with a Fluke ion chamber survey meter (reading 430 mR/hr) on February 15, 2019 at approximately 1415 [CST].

"The Licensee notified the Manufacturer and the Manufacturer will be performing an investigation on the tubing and on the radioactive sealed sources.

"There were no spills and/or contamination during this event.

"The Department is waiting on information from the Licensee regarding the Manufacturer's investigation. The Department will update this report when the Licensee provides additional information.

"Corrective Actions: In Process by Licensee and Manufacturer."

Notified the R4DO (Werner), NMSS Events (via email).

* * * UPDATE FROM ANGIE HILL TO HOWIE CROUCH VIA EMAIL ON 4/24/19 AT 1708 EDT * * *

"The Department received a report on April 24, 2019 (dated April 4, 2019) from the Licensee regarding the Y-90 TheraSphere misadministration.

"The Department requested additional information on April 24, 2019, regarding the information provided by the Licensee. The request includes clarification from the manufacturer's report and the Licensee's corrective actions.

"The Department will update this report when the Licensee provides additional information."

Notified R4DO (Young) and NMSS Events (via email).

* * * UPDATE FROM ANGIE MORGAN HILL TO HOWIE CROUCH VIA EMAIL ON 6/4/19 AT 1150 EDT * * *

The following information was obtained from the state of Arkansas via email:

"The Licensee has submitted to the Department the Manufacturer's Report, possible Root Cause and Corrective Actions.

"According to the Manufacturer's Report, it states 'the most likely cause of this event is insufficient flow rate due to high backpressure associated with the microcatheter.' 'BTG [the manufacturer] recommends following the TheraSphere package insert guidance for the selection of a microcatheter with an inner diameter that is equal or larger than 0.020 inch.' The Manufacturer's Report also states, in part, 'A review of the manufacturing records confirmed there were no device defects.'

"It is noted by the Licensee that the Authorized User prescribed a different size microcatheter from the Manufacturer Recommendations and Manufacturer's package insert.

"The Licensee states regarding the root cause, 'After testing the tubing and catheter, it was determined that the event was caused by insufficient flow through the microcatheter possibly caused by overall length and inner diameter of the microcatheter, septum fragments from the dose vial, and possible changes in the condition of materials during the time from treatment to inspection (e.g. dried saline, coiled in tight bends for extended time.' 'Having several potential causes and contributing factors, the root cause is still not known.'

The Licensee states that their corrective actions to prevent reoccurrence are '(1) continue to abide by our standard operating procedure of performing three flushes, ensuring the electronic dosimeter, or rados, is reading zero, and surveying the patient; (2) Flush an additional time with 20 mL of saline after the rados reads zero; (3) Will use a catheter with a diameter greater than or equal to 0.02 inches. A smaller catheter will only be used if the patient would otherwise be unable to receive the treatment due to small vessels.'

The Department did not issue any Items of Noncompliance for this medical event.

The Department considers this event closed.

Notified R4DO (Kellar) and NMSS Events Notification (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.