Event Notification Report for December 17, 2024

EN Revision Imported Date: 12/17/2024

EN Revision Text: AGREEMENT STATE REPORT - MEDICAL EVENT

The following information was provided by the Illinois Emergency Management Agency (the Agency) via phone and email:

"On December 4, 2024, while administering Y-90 microspheres to a patient for radioembolization of the liver, a portion was shunted to the gastrointestinal tract. The shunting was not identified in the licensee's pre-administration macroaggregated albumin (MAA) mapping. The shunting is estimated to have resulted in approximately 100 cGy (rem) to the patient's stomach. The patient and physician have been notified. The licensee has not been reachable for additional details and a site visit is being coordinated."

* * * RETRACTION ON 12/16/2024 AT 1448 FROM GARY FORSEE TO IAN HOWARD * * *

"The Agency conducted a reactive inspection on 12/11/24. Inspectors spoke with the authorized user (AU) to determine if shunting to non-treatment sites had been assessed in advance of the administration in accordance with the manufacturer's instructions. Proper shunting calculations had been performed for the lung and no additional non-treatment sites were identified. The licensee had performed an angiogram to evaluate GI flow on the day of procedure with nothing unique noted. Specifically, no GI flow was observed. The AU continued with administration to segment 4 of the liver using a Progreat 2.4Fr by 130 cm microcatheter, lot numbers: 240701 (exp. 6/30/26) and 240619 (exp. 5/31/26). No pressure, blockage or other abnormalities were encountered during administration. Nothing new or unique about the target or delivery was reported or identified. However, upon performing post-administration PET scans, uptake to the stomach was observed. The Agency has seen an increased number of licensees performing post administration PET scans and as a result, licensees are now able to visualize shunting to other organs. For example, in this case, without the post administration scan, the uptake to the stomach would not be known.

"The inspector's reactive inspection memorandum is pending and this report will be updated with additional details. However, at this point, both the physician and the inspectors believe the shunting to the stomach was due to the vasculature of the patient and not improper catheter placement. As a result, this medical event is being requested for retraction. This report is being kept open pending addition of the inspector's detailed findings."

Notified R3DO (Stoedter), NMSS (Allen), 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.

BROKEN RADIOGRAPHY SOURCE CABLE

The following information was provided by the licensee via email:

"On 11/07/2024, a radiographic crew was performing radiographic testing (RT) on a lease in Prudhoe Bay, AK (about 15 minutes from the Prudhoe Bay field station), when they noticed their camera (Sentinel 880 Delta, serial number: D3963, Ir-192 source model # A424-9, serial number: 96639M, 65.9 Ci) did not lock the source into the safe position. After attempting to check the lock with the same result, they initiated the proper notifications to the site radiation safety officer (RSO), management and drill site operator.

"At 1030 YST, the crew contacted management after extending and verifying their boundaries. They were instructed to wait for retrieval personnel and monitor their boundaries. The retrieval personnel consisted of a trained and certified retrieval RSO and experienced retrieval employees.

"The retrieval crew arrived on-site at 1100. The scene was immediately assessed, boundaries verified, dosimetry checked, and no one was over exposed to radiation. A short meeting with the RT crew and retrieval personnel followed. It was determined that the exposure device was hanging about six feet off the ground on ropes attached to a pipe above it, and the collimator was pointing upward of the building where their exposure was being taken. Once the initial information was gathered, a conference call was initiated with offsite RSO, and management began to form a plan for locating the source.

"The collimated guide tube and camera were safely lowered to the floor. Once the collimator was on the floor it was shielded. The team determined that the source may have disconnected. To verify, the crew cranked the cable all the way in to see if they could confirm the connector either came off or broke off into the pigtail. They attempted to unscrew the back of the camera but were unable to loosen one of the screws. It was decided to disconnect the safety connector off the cranks from the crank cable housing unit. In doing so, it was found that the 550 connector had broken. A plan was formulated to retrieve the source.

"The drive cable connector broke on the shoulder of the connector between the ball and the crimp, closer to the crimp. How or why is under investigation with QSA. This prevented the retrieval personnel from removing the drive cable from the camera in their attempts to retract the source. The safety connector of the cranks from the crank housing unit had to be removed before moving forward.

"QSA Global has the equipment involved in this incident and are investigating the cause of the mechanical failure.

"Event exposures:
Radiation worker 1: 50 mR film badge, 211 mR ring finger.
Radiation worker 2: 67 mR film badge, 47 mR ring finger.
Radiation worker 3: 43 mR film badge, minimal reading ring finger.
Radiation worker 4: 68 mR film badge, ring finger not used."

AGREEMENT STATE REPORT - MISSING TC-99M GENERATOR PACKAGE

The following report was received from the Massachusetts Radiation Control Program (the Agency) via email:

"On 12/10/2024, at around 1500 EST, Lantheus Medical Imaging, Inc. (license number 60-0088) was notified that a package containing a 1 Ci Mo-99/Tc-99m generator in a type B package was missing in transit and notified the Agency at 1545 on the same day.

"The reporting requirement is immediate per 105 Code of Massachusetts Regulations (CMR) 120.281(A)(1), missing licensed radioactive materials in aggregate quantity equal to or greater than 1,000 times quantity specified in 105 CMR 120.297, Appendix C.

"The Agency considers this event to be open."

Generator Model: Technelite-LEU 37.0 GBq Domestic
Generator Serial Number: B338411A04
Shipped to Southwest Health Systems in Cortez, Colorado.
Deemed lost by common carrier on 12/10/2024. The most recent reported location was Memphis, TN.
Activity: 37 Gbq, Mo-99/Tc-99m
Calibration date: 12/03/2024
Shipped as Yellow III, TI of 1.3

* * * UPDATE ON 12/11/2024 AT 1335 EST FROM ROBERT LOCKE TO JORDAN WINGATE * * *

"At 1318 EST on 12/11/2024, the licensee reported that the missing package had been delivered to its intended destination. The Agency considers this event closed."

Notified R1DO (Jackson), NMSS Events Notification (email), and ILTAB (email).

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 - STUCK OPEN SHUTTER

The following information was provided by the Illinois Emergency Management Agency (the Agency) via phone and email:

"The Agency was contacted on 12/10/2024 by representatives for Equistar Chemicals, LP (IL-01737-01) in Morris, IL, to report a fixed gauge shutter stuck in the open position [that was discovered on 12/9/2024]. The gauge is installed on the side of a process vessel and is normally in the open position. The shutter will remain in its normally open position and there will be no vessel entry. There are no changes in radiation levels except [expected levels resulting from] not being able to close the shutter. Entry to [the vessel] requires complete shutdown of the process line, and none are currently scheduled. The manufacturer's representative is on site today, 12/10/2024, to troubleshoot and make appropriate repairs. There are no exposures reported or anticipated as a result of this issue.

"Agency inspectors are coordinating a site visit to determine the root cause and corrective action. The licensee has provided a preliminary assessment that moisture can enter the housing and cause corrosion in the shutter. This report will be updated when additional information is available."

AGREEMENT STATE REPORT - LOST EXIT SIGNS

The following is a summary of information provided by the Colorado Department of Public Health and Environment via email:

Two tritium exit signs were determined to be lost by the licensee.

Manufacturer: Isolite Corporation
Number of signs: 2
Model: BX-10-BK
Activity: 9.21 Ci each, H-3

The signs were discovered missing during an annual fire inspection on 03/05/2024.

Notifications: Colorado Regulations Section 4.51.1.1 (10 CFR 20.2201(a)(1)(i))

Colorado Event Report ID Number: CO240030


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