ENS Event | |
|---|---|
05:00 Dec 8, 2006 | |
| Title | Shift of I-125 Seeds After Implantation |
| Event Description | On 10/26/06 the licensee implanted a patient with 104 seeds of I-125 (total activity of 42.2 millicuries, manufactured by Bard, Inc.) to treat prostate cancer. The post implant CT performed on 12/08/06 indicated that the distribution of the seeds was inferior to the intended distribution. A percentage of the seeds had shifted approximately 1.5 cm inferior to what was intended. The licensee is still evaluating at this time what percentage of the seeds intended for the prostate were no longer in the prostate . The licensee immediately informed the patient and the prescribing physician. The patient has to this point shown no ill effects from the migration. However, a quantity of the seeds have migrated to the perineum. Due to the unknown quantity of seeds in the perineum the licensee is still investigating the amount of dose received in this area.
The licensee is investigating the cause of the migration. After the cause is determined they will put corrective actions in place to prevent reoccurrence. The licensee has performed multiple implants that were close to 100% successful since this occurrence. The licensee intends to supplement the patients treatment with an external bean in order to achieve the intended dose. The licensee notified NRC Region 1 (S. Gabriel, P. Lanzisera)
Based on discussion with NRC Region 1 (S. Gabriel), the licensee provided the following revision to the initial event report: On October 25, 2006, the licensee implanted 104 I-125 seeds into a patient for the treatment of prostate cancer. The total activity of the implanted seeds was 42.4 mCi. A post-implant CT performed on December 8, 2006, indicated that the seed were misplaced approximately 1.5 cm inferior to the intended position. The licensee is still evaluating the details of the post-implant dosimetry. Notifications pursuant to 10 CFR 35.3045 were made on December 8, 2006. The licensee is still evaluating the cause of the misplacement of the iodine seeds. After the cause(s) has been determined, corrective actions will be put in place. The patient will require will require further treatment of the prostate gland. External beam therapy will be used to supplement the dose to prostate. 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 | |
|---|---|
| Kennedy Memorial Hospital Turnersville, New Jersey (NRC Region 1) | |
| License number: | 29-15459-01 |
| Organization: | Kennedy Memorial Hospital |
| Reporting | |
| 10 CFR 35.3045(a)(1) | |
| Time - Person (Reporting Time:+10.82 h0.451 days <br />0.0644 weeks <br />0.0148 months <br />) | |
| Opened: | Lester Tripp 15:49 Dec 8, 2006 |
| NRC Officer: | Jason Kozal |
| Last Updated: | Dec 11, 2006 |
| 43039 - NRC Website
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Kennedy Memorial Hospital with 10 CFR 35.3045(a)(1) | |
WEEKMONTHYEARENS 430392006-12-08T05:00:0008 December 2006 05:00:00
[Table view]10 CFR 35.3045(a)(1) Shift of I-125 Seeds After Implantation 2006-12-08T05:00:00 | |