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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 4523730 July 2009 13:00:0010 CFR 35.3045(a)(1)Potential Medical Event Involving Novoste Beta-Cath Strontium Brachytherapy System

The licensee reported that a patient was undergoing brachytherapy treatment of the heart. During the procedure, it was determined that the source was not in the proper position. The sources were retracted and the procedure reattempted. During the reattempt, it was determined that the sources were not going into the proper position. However, the licensee was not able to retract the sources into the Novoste device. The physician removed the catheter and device as an assembly and placed in a safe box. The licensee does not know the failure mode with any degree of certainty and is sending the device to the manufacturer for evaluation. The cardiologist believes it may have been a kink in the catheter. The patient was notified of the event, and the licensee discussed the issue with NRC Region 3(G. Warren). The device is a Novoste Beta-Cath, Device number: 86865, and source number: ZB551. 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.

  • * * RETRACTION FROM DENNIS SZMANIA TO VINCE KLCO ON 12/23/2009 @ 1056 EST* * *

The licensee is retracting the event because the source never entered the patient's body and the exposure to the patient was negligible. Notified the R3DO(Kunowski) and FSME (Villamar).