Update Regarding Unintended Heating Associated with the Monteris Medical NeuroBlate Probe
The FDA is providing an update about the potential for unintended heating and patient injury with use of the Monteris Medical NeuroBlate probe, a part of the NeuroBlate System. In our March 22 letter to health care providers, the FDA provided preliminary information about a Class I recall for the device due to several instances of unintended heating and damage to the probe, which may have resulted in unintended damage to surrounding brain tissue. Monteris Medical has received FDA clearance for a new probe which contains a non-metallic fiber optic temperature sensor to address unintended probe heating in the magnetic resonance (MR) environment. This replaces the metallic thermocouple temperature sensor of the original design. The safety risks associated with the use of the probe with the metallic thermocouple temperature sensor still remain.
Users can contact Monteris Medical to find out more about the timeline for availability of the new probe with the non-metallic fiber optic temperature sensor. Until the new probe with the fiber optic temperature sensor is available, health care providers should consider the benefits and risks of the probe with the metallic thermocouple, as well as the availability of alternative treatment modalities.
The FDA also issued an update to the April 2018 letter to health care providers on Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry to encourage safe use of MR thermometry so health care providers and patients can make informed patient management decisions about their treatment options.
RECOMMENDATIONS
The FDA recommends:
- Until the new NeuroBlate probe with the fiber optic temperature sensor is available, health care providers should consider on an individual patient basis, the benefits and risks of the probe with the metallic thermocouple, as well as the availability of alternative treatment modalities.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
The FDA will keep the public informed if any significant new information or recommendations become available.