ENS 43819
ENS Event | |
|---|---|
15:00 Aug 8, 2007 | |
| Title | Agreement State Notification - Medical Event Involving Iodine 125 Seeds |
| Event Description | The State provided the following information via facsimile:
On August 8, 2007 a patient presented to Longmont United Hospital, Colorado Radioactive Materials license #73-01, for implantation of I-125 seeds into the prostate for treatment of adenocarcinoma of the prostate. The Authorized User was Radiation Oncologist [DELETED], MD; the surgeon was [DELETED], MD; the Authorized Medical Physicist was [DELETED], MS. In the course of the operative procedure, some seeds were placed inferior to the prostate rather than into the gland itself. Due to the misplacement of the seeds, the total dose to the prostate differed from the prescribed dose by more than 20%. The prescribed dose to the prostate was 160 Gy. A total of 63 0.476U Bard Model STM 1251 [seeds] were implanted. [Total activity 0.3 milliCurie per seed]. Post-implant dosimetry was performed, based on a CT scan of pelvic region. The mean dose to the prostate was 14.4 Gy, the mean dose to the rectum was 44.7 Gy, and the mean dose to the urethra was 73.4 Gy. No other critical structures were substantially irradiated. At the root of this event was displacement of the prostate gland that was not detected by image guidance caused by substantial peri-prostatic bleeding and hematoma formation. The tissues adjacent to the prostate provided an image with features mimicking the appearance of the prostate, though with non-distinct borders. Due to the bleeding, even these non-distinct borders were expected. In short, enough plausible indicators of correct positioning were present that the surgical team proceeded with the implant until the misplacement of the seeds was discovered. Due to the unusual circumstances of this specific procedure, no underlying deficiency in the prostate brachytherapy program of this licensee is indicated. The program has since implemented the use of stabilization needles at initiation of the implantation procedure. The primary element deserving of attention lies in the inherent dependence upon the ultrasound image. In such rare cases as this of limited visualization, it may behoove all users to use alternative methods to verify position, such as the digital exam performed on this patient or fluoroscopic visualization of the anatomy. It might be recommended to perform the verification in such circumstances prior to the implantation of any seeds. The spouse of the patient was informed immediately after the surgical procedure, and the patient was informed when he regained his faculties after anesthesia. The CT scan was performed later that day for dosimetric purposes. It is understood that the notification provided in this report to your Agency [State of Colorado] should have occurred within 15 days of the event. However, there was miscommunication between the Licensee and the QMP, each thinking that the other had made the report. [Licensee] apologizes for this delay. In the future if such an event should occur, a single person will be appointed to submit a report so that this confusion will not occur again. A total of 23 milliCuries from 63 seeds were implemented during this procedure. 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 | |
|---|---|
| Longmont United Hospital Denver, Colorado (NRC Region 4) | |
| License number: | 73-01 |
| Organization: | Colorado Dept Of Health |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+2807.35 h116.973 days <br />16.71 weeks <br />3.846 months <br />) | |
| Opened: | Jennifer Opila 15:21 Dec 3, 2007 |
| NRC Officer: | Joe O'Hara |
| Last Updated: | Dec 3, 2007 |
| 43819 - NRC Website | |
Longmont United Hospital with Agreement State | |
WEEKMONTHYEARENS 438192007-08-08T15:00:0008 August 2007 15:00:00
[Table view]Agreement State Agreement State Notification - Medical Event Involving Iodine 125 Seeds 2007-08-08T15:00:00 | |