The following information was received via facsimile:
NY-06-005
Intravascular Brachytherapy event. (NYS DOH Internal Tracking No. 223)
New York law prohibits the release of any identities in cases of medical events. Therefore the facility name, etc., is not contained in this report.
RSO of the hospital called to report that on May 26, 2004, during the introduction of Novoste Sr-90 (3.5 French catheter with the 40mm source train) it was noted, on fluoroscopy that the sources did not advance into the intended target tissue site in the right coronary artery. The licensee used a survey meter to confirm the source train was not in its intended position (rough check). The measurement served to confirm that the source train advanced partially and became stuck in the patient's abdomen. Emergency procedures were followed and all sources were removed within 30 seconds from the 63 [year old] female patient. The catheter assembly containing all sources was placed into a Lucite shield (bailout box). Confirmation of the stuck sources in the transfer case was obtained through fluoroscopy and indicated that the sources were trapped 13 cm from the distal end of the guide catheter. The patient was informed of the event and was subsequently treated with a stent.
This is reportable under 10 NYCRR 16.25(a)(3)&7 (part of the body other than intended and total dose deviation greater than 10 %). The hospital will send the catheter back to Novoste for an evaluation and will submit a written report following Novoste written analysis.
The incident reports from the facility, as well as from Novoste, were provided to DOH. Novoste provided guidance to avoid a recurrence.