March 22, 2018

Dear Health Care Provider,

The FDA is providing preliminary information about the potential for unintended heating and patient injury with use of the Monteris Medical NeuroBlate probe, which is part of the NeuroBlate System, and bringing to your attention a Class I recall for the device. A Class I recall is the most serious type of recall and is issued when use of the device may cause serious injuries or death. Monteris issued three product advisories between October and December 2017, which were part of the Class I recall; however, the FDA has concerns that the information provided by Monteris has not sufficiently mitigated the risk of unintended probe tip heating. We are working with the manufacturer to address these concerns.

The NeuroBlate® System by Monteris Medical is indicated to ablate, necrotize, or coagulate soft tissue in the brain through interstitial irradiation or thermal therapy in neurosurgical procedures with 1064 nm lasers. It is intended for planning and monitoring thermal therapies under MRI visualization, and provides MRI-based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) NeuroBlate Laser Delivery Probes. It also provides real-time thermographic analysis of selected MRI images.

The device is currently the subject of a voluntary recall which was initiated by the firm, and classified as Class I by the FDA, due to several instances of unintended heating and damage to the probe, which may have resulted in unintended damage to surrounding brain tissue. The damage to the probe appears to have been caused by an interaction between the thermocouple in the probe, and the MRI environment. These events occurred independent of laser energy delivery, and have been associated with damage to the tip of the probe implanted within the brain (e.g., charring, release of carbon dioxide). The FDA has received medical device reports (MDRs) related to overheating of the probe, including one report of a patient who experienced an intracranial hemorrhage and died, although causality with the device malfunction cannot be concluded with certainty.

RECOMMENDATIONS FOR HEALTH CARE PROVIDERS:

• Be aware of the Class I recall associated with the NeuroBlate System’s unintended probe heating and the potential clinical consequences associated with that.
• Until appropriate mitigation strategies have been identified by the manufacturer and evaluated by the FDA, health care providers should strongly consider treating patients using alternative procedures if available. The benefits and risks of the device, as well as the availability and benefits and risks of alternative treatment modalities, should be considered on an individual patient basis. Health care providers who do not believe there is a viable alternative should use the device with extreme caution.
• 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.

FDA ACTIONS

The FDA will continue to work with the firm and gather and evaluate data related to this safety issue. We will update this communication when significant new information becomes available.

CONTACT US

If you have questions about this communication, please contact CDRH’s Division of Industry and Consumer Education (DICE) at [email protected], 800-638-2041, or 301-796-7100.

Sincerely,
/s/
William Maisel, MD, MPH
Deputy Center Director for Science
Center for Devices and Radiological Health
U.S. Food and Drug Administration