NeuroBlate Probe May Overheat, FDA Class I Recall Warns

Megan Brooks

Disclosures

March 22, 2018

In a safety communication issued today, the US Food and Drug Administration (FDA) provides preliminary information about the potential for "unintended heating and patient injury" with NeuroBlate laser delivery probes, part of the NeuroBlate System (Monteris Medical).

The company initiated a voluntary recall of the NeuroBlate probe and system on October 5, 2017. The FDA labeled it a Class I recall based on several instances of unintended heating and damage to the probe, which may have resulted in unintended damage to surrounding brain tissue.

NeuroBlate laser delivery probes are small, CO2-cooled catheters that allow minimally invasive entry into the brain. The probes and system are used during surgical procedures to remove, coagulate, or destroy cells in brain tissue.

NeuroBlate laser delivery probes may interact with MRI used to visualize the position of the catheter and cause unexpected heating and damage to the tip of the probe. This could cause unanticipated heating of surrounding brain tissue, or damage the tip of the probe, and allow the CO2 cooling gas inside the probe to leak into the brain, the FDA says.

The agency says it has received Medical Device Reports related to overheating of the probe, including one involving a patient who suffered intracranial hemorrhage and died.

The FDA wants healthcare providers to be aware of the Class I recall related to the system's unintended probe heating and the potential associated clinical consequences.

"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 FDA advises.

"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," they conclude.

Healthcare professionals are encouraged to report problems with the NeuroBlate System to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.   

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