ENS 48225
ENS Event | |
|---|---|
04:00 Aug 6, 2012 | |
| Title | Agreement State Report - Possible Medical Event Related to Use of I-125 Seed Mesh Implant |
| Event Description | The following report was received from the North Carolina Radiation Protection Section via e-mail:
On August 6, 2012 [the North Carolina Radiation Protection Section, NC-DHHS, RPS] received notice of a possible device failure. [Follow-up by NC-DHHS, RPS was conducted on August 8, 2012, by contacting the Authorized Medical Physicist (AMP)]. A patient was given an invasive procedure (to right lung) using a mesh that contained permanent I-125 seeds attached as an implant. The implant contained 50 seeds with 5 strands of 10 seeds per strand. The total activity was 16.4 mCi on May 31, 2012. The patient was discharged from hospital on June 9, 2012. [The] patient was readmitted to the hospital on July 4, 2012. On July 7, 2012, x-rays revealed an abscess in the right lung with approximately 38 notable seeds in place. On July 9, 2012, the radiation oncologist requested chest and abdomen films. At that time, 35 seeds were noted in the right lung with 3 located in the abdomen. Per the patient; he was coughing up phlegm and subsequently swallowing it. The patient was made aware of seed mobility. On July 18, 2012 (decayed to 0.187 mCi/seed), there were 13 seeds confirmed in the lung and 17 seeds in the abdomen (total 5.62 mCi). Upon out-patient visit on July 4, 2012, there were 6 seeds remaining in the chest and 8 in the abdomen; there were no appreciable side effects noted per the radiation oncologist. Nine seeds were recovered during the patient's hospitalization and placed in the Nuclear Medicine Hot Lab. The device manufacturer was notified by immediate supervisor. The above information was received August 6, 2012 via electronic mail and August 10, 2012 via letter. The below information was received August 20, 2012 via electronic mail. 'This is the follow-up letter as requested in our conversation on Aug 08, 2012. To review, on May 31, 2012, fifty Iodine-125 seeds were implanted in a patient as a permanent implant in the right lung. The activity was 16.4 mCi on that date. Upon re-admission into the hospital, a chest x-ray was done on July 07. Approximately 38 of the 50 original seeds were visible on that date. If one merely accounts for the change in seed count (38/50), the area of the right lung implant received 76% of its intended dose. Therefore, the total dose delivered differs from the prescribed dose by 20% or more. 'This describes a Medical Event, as defined by section 15A NCAC 11.0364 (1) (A). 'On August 08, the patient came to the Radiation Oncology department. Final x-rays revealed no seeds within the lungs or abdomen. 'As an additional note, the failure of the device has been reported to the FDA by our hospital administration and the company that manufactures the device.' (Intended dose appears to be 25 Sv/hr at .1 cm (contact) on June 9 50 seeds = 16.4 mCi = 25 Sv/hr@ .1 cm (contact) .328 mCi/seed initial activity On day number 25 (July 4) 38 seeds remain in lung (.328 mCi/seed with 1/2 life factor = .245 mCi/seed) 38*.245 mCi= 9.31 mCi = 14.67 Sv/hr@ .1 cm (contact) If all seeds were intact the result would be 12.25 mCi -> resulting in a 9.31 mCi/12.25 mCi = 76% A device NMED notification maybe required and have requested such from the AMP. More to follow. 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 | |
|---|---|
| Frye Regional Medical Center Hickory, North Carolina (NRC Region 1) | |
| License number: | NC #018-0377- |
| Organization: | Nc Div Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+420.83 h17.535 days <br />2.505 weeks <br />0.576 months <br />) | |
| Opened: | Randy Crowe 16:50 Aug 23, 2012 |
| NRC Officer: | Bill Huffman |
| Last Updated: | Aug 23, 2012 |
| 48225 - NRC Website | |
Frye Regional Medical Center with Agreement State | |
WEEKMONTHYEARENS 482252012-08-06T04:00:0006 August 2012 04:00:00
[Table view]Agreement State Agreement State Report - Possible Medical Event Related to Use of I-125 Seed Mesh Implant 2012-08-06T04:00:00 | |