ENS 56686
ENS Event | |
|---|---|
04:00 Aug 17, 2023 | |
| Title | Medical Event - Patient Underdose |
| Event Description | The following information was provided by West Virginia University Hospital via telephone and email:
It was determined on 8/21/2023, that during a Y-90 (yttrium-90) Thera Sphere treatment performed on 8/17/2023, the delivered dose differed from the prescribed dose by more than 20 percent. The prescribed activity was 101.5 mCi and the administered activity was 3.4 mCi. At the start of the infusion the authorized user (AU) was unable to deliver the microspheres due to a blood clot in the microcatheter. The AU then decided to abort the infusion and reschedule instead of chancing potential contamination that could occur by changing out the microcatheter. The AU had completed the pre-treatment safety checklist with no issues. The AU has made the notification to the referring physician. 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.
It was determined that the dose of yttrium-90 Thera Spheres was not delivered according to the written directive due to an emergent patient condition. Therefore, the incident does not qualify as a reportable medical event. The patient's blood formed a clot within the microcatheter which prevented the passage of Y-90 microspheres. At the onset of administration, the Authorized User (AU) encountered significant resistance in the microcatheter, and they could not flush forward. When troubleshooting the delivery set, the AU visually identified the blood clot within the microcatheter. After several unsuccessful attempts to clear the blood clot, and in consultation with representatives from Boston Scientific, the AU decided to terminate the procedure. On September 1st, the Y-90 prescribed activity, as stated on the written directive, was successfully administered to the patient's hepatic artery. There were no adverse effects to the patient because of the underdose incident. The details of this incident were discussed with NRC inspectors who were on site for a reactive inspection. During those discussions it was concluded that since the patient's blood clotted within the microcatheter, the inability to complete the administration was due to an emergent patient condition. The blood clot within the microcatheter was confirmed by an analysis of the delivery set performed by Boston Scientific's Product Analysis Team. Notified: R1DO (Elise), NMSS Events Notification (E-mail) |
| Where | |
|---|---|
| West Virginia University Hospital Morgantown, West Virginia (NRC Region 1) | |
| License number: | 47-23066-02 |
| Organization: | West Virginia University Hospital |
| Reporting | |
| 10 CFR 35.3045(a)(1) | |
| Time - Person (Reporting Time:+107.27 h4.47 days <br />0.639 weeks <br />0.147 months <br />) | |
| Opened: | Stephen Root 15:16 Aug 21, 2023 |
| NRC Officer: | Karen Cotton-Gross |
| Last Updated: | Nov 7, 2023 |
| 56686 - NRC Website
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West Virginia University Hospital with 10 CFR 35.3045(a)(1) | |
WEEKMONTHYEARENS 566862023-08-17T04:00:00017 August 2023 04:00:00
[Table view]10 CFR 35.3045(a)(1) Medical Event - Patient Underdose ENS 529492017-09-05T20:30:0005 September 2017 20:30:00 10 CFR 35.3045(a)(1) Brachytherapy Treatment Delivered Dose Less than Prescribed Dose ENS 460742010-01-20T04:00:00020 January 2010 04:00:00 10 CFR 35.3045(a)(1) Medical Treatment Terminated Prior to Administering Full Dose 2023-08-17T04:00:00 | |