The US FDA has alerted doctors to a problem with the Monteris Medical NeuroBlate probe in which the device may become unexpectedly heated during certain types of brain surgery.
The FDA has provided 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 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 haemorrhage and died, although causality with the device malfunction cannot be concluded with certainty. 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.