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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 56619 | 11 July 2023 21:00:00 | 10 CFR 35.3045(a)(2) | Medical Event - Dose Misadministration | The following information was provided by the licensee via phone: On July 11, 2023, at 1700 EDT, an intravascular brachytherapy treatment was delivered to the wrong treatment site. The original dose of 23 Gy was intended for a different part of the vasculature system. The brachytherapy device made by Best Vascular is a Beta-Catch (model # 5ICW-2) containing 3.62 GBq of Sr/Y-90. Physicians expect that there will be no permanent damage to any of the patient's organs. 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. | ||
| ENS 56512 | 8 May 2023 04:00:00 | 10 CFR 35.3045(a)(2) | Potential Medical Event | The following information was provided by the licensee via phone and email: In accordance with 10 CFR 35.3045, (Henry Ford Hospital is) reporting a potential medical event. On May 8, 2023, a patient was treated with Y-90 TheraSpheres. The total activity prescribed in the written directive was 11.5 mCi to the left lobe of the liver and 11.37 mCi was delivered (99.2 percent). The therapeutic dose was prescribed to be delivered to segment 4 of the left lobe of the liver. During treatment, the position of the catheter was verified and was determined by the physician to be in the correct position. However, post-treatment bremsstrahlung imaging reviewed today on 5/9/2023 indicated some activity was shunted unexpectedly to segments 2 and 3 of the left lobe of the liver. Based on preliminary calculations, this discrepancy could be categorized as a medical event.
The following information was provided by the licensee via phone: Since the exposure was due to shunting, the licensee determined that this event is not reportable in accordance with the licensing guide. This event is being retracted. Notified R3DO (Feliz-Adorno), NMSS (Rivera-Capella), and NMSS Events Notification. 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. | ||
| ENS 56139 | 3 October 2022 16:10:00 | 10 CFR 35.3045(a)(3) | Medical Event - Incorrect Written Directive | The following information was provided by the licensee via phone: On 10/3/22, a medical event occurred when a written directive was incorrect. The nuclear medicine staff recognized the written directive was incorrect and delivered the correct dose to the proper location. The patient was not harmed. 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. | ||
| ENS 52933 | 28 August 2017 11:00:00 | 10 CFR 20.1906(d)(1) | Receipt of a Contaminated Package | This incident is being reported under 10CFR20.1906(d) and 10CFR71.87(i). A contaminated package was received from Cardinal Health at approximately 0700 EDT on 8/28/17. The package contained 49.41 mCi of I-131 and had removable surface contamination. The first wipe test exhibited 0.4 microCi/300 sq. cm Tc-99m and the second wipe was 0.25 microCi Tc-99m/300 sq. cm. The interior of the package was not contaminated. The package was isolated pending disposition. Cardinal Health was contacted. Their delivery van and driver were surveyed and exhibited no contamination. | ||
| ENS 52524 | 31 January 2017 15:51:00 | 10 CFR 35.3045(a)(1) 10 CFR 35.3045(a)(3) | Potential Medical Event | A patient at the Henry Ford Hospital Interventional Radiology Department was prescribed a Y-90 Theraspheres treatment of 60 Gray to the left lobe of the liver. The Interventional Radiologist administered 46 Gray total to both the right and the left lobe of the liver. The referring physician has been notified and the licensee has notified the patient. It is believed that this event will not result in any harm to the patient. The licensee is in the process of determining corrective action to prevent reoccurrence. 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. | ||
| ENS 51640 | 6 January 2016 15:27:00 | 10 CFR 35.3045(a)(1) | Potentially Reportable Underdose to Patient | A patient at the Henry Ford Hospital Interventional Radiology Department received a Y-90 Theraspheres treatment of 120 Gray to a portion of the left lobe of the liver via a written directive from the referring physician. The Interventional Radiologist administered the prescribed dose to the entire left lobe of the liver, and the hospital believes that will result in an underdose to the patient. The exact amount of the underdose has not determined at the time of this report. The referring physician has been notified and the licensee will inform the NRC when the patient has been notified. It is believed that this event will not result in any harm to the patient. The licensee is in the process of determining corrective action to prevent reoccurrence.
The following update information was provided by the licensee via email: Providing additional materials related to a potential medical event that was reported on January 7, 2016 by Henry Ford Hospital (License 21-04109-16; Docket: 030-02043). Hospital reported an apparent deviation from the written directive of a Y-90 TheraSpheres treatment done on January 6, 2016. The written directive was prepared in tandem by a Radiation Oncologist and a Nuclear Medicine Authorized User physicians for the major portion of the left lobe of the liver, omitting segments 4A and 4B. The entire left lobe of the liver, including segments 4A and 4B, was treated by the Interventional Radiologist. The written directive called for the administration of 2.3 GBq (62.2 mCi) of Y-90. The activity delivered was 2.37 GBq (64 mCi) which properly conformed with the activity specified in the written directive. However, the dose delivered to the liver deviates from the intended dose in two important ways. First, the written directive did not include treating segments 4A and 4B of the left lobe of the liver. Secondly, the dose delivered of 94 Gy (9,400 rad) to the left lobe of the liver was lower (21.5%) than the intended dose of 120 Gy (12,000 rad). The Interventional Radiologist, who is the referring physician for this patient, originally intended to treat the entire left lobe of the liver, including segments 4A and 4B. This Interventional Radiologist, while very experienced in TheraSpheres treatments was new to the institution and proper communication of the intended treatment site did not occur. It is important to note that all of the physicians involved indicated that no harm resulted to the patient as a result of this deviation. According to the TheraSpheres package insert, the recommended therapeutic dose to the liver is 80 Gy to 150 Gy (8,000 rad to 15,000 rad). Thus the treatment dose of 94 Gy (9,400 rad) is well within the therapeutic range. The referring physician was notified about this case and he notified the patient about the treatment deviation. Notified R3DO (Stoedter) and NMSS Events Notification group 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. |