The following information was received via facsimile:
NY-06-006
Intravascular Brachytherapy event. (NYS DOH Internal Tracking No 278)
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.
The
RSO from the Hospital called on 9/30/04 to report a Novoste Beta Cath IVBT malfunction on 9/29/04. They were using 3.5 French catheter system. They had some difficulty accomplishing a 90-degree bend; at the end of the 3 min 14 seconds treatment time, their attempts to retract the source train failed and the cardiologist had to pull out the catheter manually along with the source train. They notified the FDA and NOVOSTE. They calculated that the patient's heart received a dose of 20 cGy, which the oncologist stated is within tolerance and he anticipates no adverse consequences for the patient. Since the intended dose was delivered to the treatment site, the oncologist believes this is not a medical event. An estimate of dose to the cardiologist's hand indicates an extremity exposure of no more than 3.85
rem which will be added to his annual exposure record.