ENS 51759
ENS Event | |
|---|---|
18:20 Feb 26, 2016 | |
| Title | Medical Event - Underdose to Patient |
| Event Description | Notification from the licensee's Radiation Safety Officer, of a medical event that occurred on February 26, 2016 at 1120 MST, in which the Y-90 SIR-Sphere dose delivered to the patient's liver was less than the prescribed dose. The intended dose to the patient was 86 mCi, however, most of the dose remained in the catheter and it is estimated the patient received 13 mCi. The patient and attending physician have been informed and there was no harm to the patient.
The following was received via email: Per NRC requirement noted in 10 CFR Subpart M, Section 30.3045 (a)(1) and 30.3045(d), this report is being submitted to provide details of a medical event that occurred on February 26, 2016. This event was previously reported by phone as required in 10 CFR, Subpart M, Section 30.345(c) on February 26, 2016 at 1836 EST to NRC Operations Center. Patient was to receive 3.1 GBq of Y90 Theraspheres for treatment of right liver lobe hepatocellular carcinoma. Assay dose of 3.2 GBq was prepared via manufacture protocol and brought to the Interventional Radiology Suite and placed into the delivery apparatus. Manufacturer representative was on-site and provided further instruction on apparatus setup of infusion lines. Surefire catheter was deployed in the same location of the initial pre-treatment planning procedure. After angiography confirmed this position, the Theraspheres product was delivered and the entire delivery apparatus was removed from the patient and placed in the appropriate waste jar. After the infusion, and per protocol, post implantation measurements were taken both of the patient and infusion set. It was discovered that the patient's readings were significantly lower than expected along with higher readings than expected within the infusion line. Per protocol the patient was imaged post Y90 implantation which demonstrated activity noted in the target location. The radiologist's interpretation of that exam notes activity within target area with no activity seen in the chest or abdomen, outside the intended target area. Review of final calculations indicates that the patient received .491 GBq which was approximately 15% of the written directive. Imaging of the infusion lines within the waste jar demonstrate activity of the Y90 Theraspheres retained within the infusion lines. After review with the Surefire catheter representative, it appears the Surefire apparatus may not have been fully extended which would have potentially provided an occlusion and prevented all of the Theraspheres from passing through the device. [The licensee is] continuing to investigate the cause. The patient was contacted 3 days post procedure to follow up to determine any symptomatic episodes. The patient stated that the patient has not felt any effects from the procedure. The patient was also seen two weeks post procedure for review of any symptoms from the procedure. The patient to date has not reported any unusual symptoms. [The licensee] ordered a different, and newer, Surefire product to use instead of the Surefire product that has been used for previous Y90 cases. [The licensee] discontinued the use of the Surefire product at issue for this procedure. The patient was notified immediately post procedure that it appeared that the patient received less than the total intended dosage of the Y90 Theraspheres. The patient has been followed within clinic as set forth above. The patient will continue to be followed as medically appropriate. Notified R4DO (Proulx) and NMSS Events Resource 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. |
| Where | |
|---|---|
| Saint Alphonsus Health System Boise, Idaho (NRC Region 4) | |
| License number: | 11-27396-01 |
| Organization: | Saint Alphonsus Health System |
| Reporting | |
| 10 CFR 35.3045(a)(1) | |
| Time - Person (Reporting Time:+0.27 h0.0113 days <br />0.00161 weeks <br />3.69846e-4 months <br />) | |
| Opened: | Eric Colaianni 18:36 Feb 26, 2016 |
| NRC Officer: | John Shoemaker |
| Last Updated: | Mar 11, 2016 |
| 51759 - NRC Website | |
Saint Alphonsus Health System with 10 CFR 35.3045(a)(1) | |
WEEKMONTHYEARENS 517592016-02-26T18:20:00026 February 2016 18:20:00
[Table view]10 CFR 35.3045(a)(1) Medical Event - Underdose to Patient 2016-02-26T18:20:00 | |