Filing a NeuroBlate Probe lawsuit may be an option for patients who suffered serious or life-threatening brain injuries in connection with the malfunction of Monteris Medical’s NeuroBlate Laser Delivery Probe. Reports of unintended heating and damage to the probe recently prompted the FDA to announce a Class I NeuroBlate Probe recall.
Victims of NeuroBlate brain injuries may be entitled to significant financial compensation. To learn if you could be eligible to file a NeuroBlate Probe lawsuit, contact the nationwide law firm of Bernstein Liebhard LLP at (888) 994-5118 for a free, no-obligation review of your case.
Monteris Medical’s NeuroBlate System combines a surgical laser, MRI imaging and software to remove (ablate), thicken or solidify (coagulate), or destroy (necrotize) cells during minimally-invasive brain procedures. The system is intended to allow neurosurgeons to remove tumors and lesions that were once considered inoperable.
The NeuroBlate Laser Delivery Probe is a small, carbon dioxide (CO2)-cooled catheter designed to allow minimally invasive entry into a patient’s brain.
Monteris Medical initiated a recall for certain NeuroBlate Laser Delivery Probes in October 2017, following reports of unintended heating and damage to the probe during procedures.
The FDA later designated the NeuroBlate recall a Class I medical device recall, which indicates that use of the probe could cause serious injury or death.
According to the agency, Monteris had issued three advisories between October and December 2017 regarding unintended probe tip heating. However, the FDA was concerned that the information provided by Monteris had not sufficiently mitigated the risk of unintended heating.
“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 agency warns. “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.”
Devices affected by the NeuroBlate Probe recall include the following models with product codes GEX and HAW:
The recall affects a total of 52 probes, including 49 sold in the United States. The remainder were sold in Canada.
The recalled NeuroBlate Probes were manufactured from April 2013 to July 2017.
According to an FDA letter to health care providers dated March 22, 2018, the issues that prompted the NeuroBlate Probe recall appear 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 agency said.
Malfunction of the NeuroBlate Probe could cause unanticipated heating of surrounding brain tissue, damage the tip of the probe, or allow the CO2 cooling gas inside the probe to leak into the brain.
The FDA acknowledged that it had received medical device reports related to overheating of the NeuroBlate Probe, including one report of a patient who died after experiencing an intracranial hemorrhage, “although causality with the device malfunction cannot be concluded with certainty.”
Victims of NeuroBlate Probe malfunctions may be entitled to compensation for all of the damages related to their brain injuries, including:
The medical device attorneys at Bernstein Liebhard LLP are offering free, no-obligation case reviews to patients who may have been harmed by a NeuroBlate Laster Delivery Probe, or their surviving family members. To learn more about your options for filing a NeuroBlate Probe Lawsuit, please call (888) 994-5118.
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