ENS 47279
ENS Event | |
|---|---|
12:00 Sep 13, 2011 | |
| Title | Agreement State Report - Medical Event Involving the Misadministration of I-125 Seeds in a Prostate Cancer Treatment |
| Event Description | The following was received from the state via e-mail:
On Thursday, September 15, the Radiation Safety Officer (RSO) for the licensee called [the state] to make a preliminary advisement that a medical event involving a prostate cancer treatment had occurred at their facility. The treatment called for the placement of seventy one I-125 seeds in the prostate. As advised by the RSO, post implant imaging revealed only 3 seeds located in the target, indicating a dose under 20 percent of the prescribed amount in the written directive was likely. Post operatively, seven seeds were discovered to be in the bladder and were immediately removed. Additional post operative imaging indicated that a number of seeds were placed in bowel wall, bladder wall, and the lumen of the bowel. Subsequent to that initial notification, the licensee conducted additional imaging and reviews of the case in order to assess the dosimetry associated with the implant. The written directive called for 145 Gray to the target and allowed for up to 100% of the reference dose to the prostatic urethra and 150% of the dose to the rectum. Preliminary estimates are that the D90 to the prostate was 2.2 Gy. The dose to the prostatic urethra was 15.3 Gy and the dose to the rectum was 63.9 Gy. Due to the misplaced application of the seeds, doses to the large bowel (10 cc), small bowel (10 cc) and bladder are also believed likely to have occurred. Those doses are 49.19 Gy, 20.7 Gy and 23.8 Gy, respectively. All estimates provided were preliminary and subject to change. The patient and referring physician were advised of the event on the day following surgery. The patient was cautioned that due to seed placement, the sources may be passed in the patient's stool and/or urine. Imaging on September 15 suggested the patient in fact passed 8 seeds since the initial implant on September 13. (Additional passages would affect dose estimates.) The patient intends to attempt a second placement procedure at the licensee's facility in order to treat the cancer. Additional corrective measures and risks were also discussed with the patient. The licensee notes that two procedural items that have been consistent with other successful treatments at their facility were not in place during this event. Fluoroscopy was not used during needle placement and the benefit of the physical presence of a medical physicist was not used. The Agency [state] intends to conduct an on-site investigation to gather additional information related to the cause of this event and review the licensee's proposed corrective action as well as review additional cases conducted at the facility. The licensee was advised of the 15 day written reporting requirement. Pending submission of that report and the Agency's investigation, this item remains open. Illinois Item Number: IL11126 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 | |
|---|---|
| Swedish American Hospital Rockford, Illinois (NRC Region 3) | |
| License number: | IL-01067-01 |
| Organization: | Illinois Emergency Mgmt. Agency |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+150 h6.25 days <br />0.893 weeks <br />0.205 months <br />) | |
| Opened: | Daren Perrero 18:00 Sep 19, 2011 |
| NRC Officer: | Joe O'Hara |
| Last Updated: | Sep 19, 2011 |
| 47279 - NRC Website | |
Swedish American Hospital with Agreement State | |
WEEKMONTHYEARENS 472792011-09-13T12:00:00013 September 2011 12:00:00
[Table view]Agreement State Agreement State Report - Medical Event Involving the Misadministration of I-125 Seeds in a Prostate Cancer Treatment 2011-09-13T12:00:00 | |