FDA warns physicians of RF device-related deaths
The warning follows notifications that the agency has received reports of deaths related to the use of the devices. According to the FDA, reports with similar findings “have appeared in the literature.”
The agency said that patient selection, subsequent treatment and technical use of the RF ablation device, including placement and operation, may have contributed to the fatalities. The FDA said it has cleared many RF devices for general ablation of soft tissue by thermal coagulation necrosis, many of which have been cleared for certain indications; however, they have not been cleared specifically for lung tumor ablation.
Manufacturers of ablation devices, including Johnson & Johnson, Boston Scientific and CR Bard, cannot legally market them for use with lung tumors because clinical data establishing their safety and effectiveness for this purpose have not been submitted to the agency, the FDA said. This stipulation includes promoting the safety and effectiveness of the devices in training programs, the agency added.