Penumbra JET 7 Catheter Lawsuit

Penumbra’s reperfusion catheter is used by many surgeons in thrombectomy procedures when removing blood clots from the veins and arteries of their patients. If you have suffered an injury due to this device, you should contact an experienced JET 7 catheter lawyer immediately.

What is its use?

As a component of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing, the JET 7 Xtra Flex catheter and JET 7MAX configuration (JET 7 Xtra Flex catheter and MAX Delivery Device) are medical devices intended to restore blood flow by removing clots using continuous aspiration in patients experiencing an acute ischemic stroke within 8 hours of symptom onset who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or those who fail IV t-PA therapy.

Is it safe?

In several reports regarding the device, arterial ruptures led to patient deaths. In some of these cases, the rupture occurred in the internal carotid artery, which supplies blood to the brain and eyes. Furthermore, some reported ruptures were associated with damage to the distal tip.

Gabriel Grego, the managing partner at Quintessential Capital Management, published a short thesis calling the Penumbra Jet 7 “unsafe and unmarketable.”

The FDA has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including:

• Deaths
• Serious injuries
• Malfunctions

Death

Of the MDRs, twenty of them describe 14 unique patient deaths, which include reports from different reporting sources for a single adverse event. Other MDRs describe serious patient injuries such as:

• Vessel damage
• Hemorrhage
• Cerebral infarction

Device Failure

Device failure modes reported in the MDRs include:

• Ballooning
• Expansion
• Rupture
• Breakage
• Complete separation
• Exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter

Additionally, Bench testing performed by the manufacturer, where the catheter distal tip is plugged and pressurized to failure, demonstrates that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other large-bore aspiration catheters.

The U.S. Food and Drug Administration (FDA) has alerted that Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of an unexpected death or serious injury while used for removing clots in stroke patients.

Recalled Devices

The devices affected by the recall include:

• The JET 7 Xtra Flex catheter, which was originally cleared under K190010 on June 16, 2019.
• The JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device) cleared under K191946 on February 27, 2020.

*Note – The recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip.

FDA Recommendations

The FDA recommends users follow all instructions provided in Penumbra’s Urgent Voluntary Medical Device Recall Notification:

• Do not use the JET 7 Xtra Flex catheter
• Remove and quarantine all unused affected products in your inventory.
• Return the affected products to Penumbra per Penumbra’s instructions.
• Complete Penumbra’s product identification/return form.
• Contact Penumbra Customer Service (order@penumbrainc.com or 1-888-272-4606)

Lastly, you should report any adverse events or suspected events experienced with the JET 7 Xtra Flex through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

If you or a loved one has suffered a Penumbra catheter injury; reporting your injury is the first step in your road to recovery. Here’s how to do so:

Report Injuries to the FDA

Voluntary reports can be submitted through MedWatch. 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 the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

When possible, reports should include the following information:

• Anatomical location, vessel size, time from symptom onset, and concomitant treatments of the vessel occlusion.
• Vessel anatomical characteristics (tortuosity).
• Whether the adverse event occurred intra-procedurally or post-procedurally.
• A complete description of the adverse event and patient outcome, if available.
• The device model names and numbers.
• Any ancillary devices used during the procedure, such as the specific trade name and size of the microcatheter, intermediate catheter, guide catheter, guidewire, and stent-retriever, if applicable.
• Any ancillary fluids or drugs used during the procedure, such as contrast agents and saline flushes, if applicable, and the delivery device used.
• A unique device identifier (UDI)

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

The civil litigation process requires extreme attention to detail and can be overwhelming for someone who does not possess extensive legal knowledge. A Penumbra JET 7 catheter lawyer will need to be able to prove the liability of another party for any injuries that you have suffered.

If you believe that you may qualify for legal action, contact TorHoerman Law for a free consultation with a JET 7 injury lawyer to discuss your legal options.

You can also use our chatbot below to receive a free, instant online case evaluation right now.

Do I qualify for a JET 7 injury lawsuit?

If you or a loved one received a JET 7 catheter device and subsequently suffered injuries or complications including:

• Vessel damage
• Hemorrhage
• Cerebral infarction
• Injuries related to device defect
• Death

you may qualify for the Penumbra JET 7 injury lawsuit.

Contact TorHoerman Law today or use our chatbot below to get a free, instant online case evaluation right now.

What to do if you qualify

If you do qualify for legal action, there are a few steps that you should take to prepare for your lawsuit:

• Mitigation
• Consultation

Mitigation

To mitigate damages is the process in which the injured party minimizes that costs & losses incurred as a result of an accident.

Some important step to mitigation include:

• Get a diagnosis of your injuries from a medical professional as soon as possible
• Seek medical treatment for all diagnosed injuries
• Follow your doctors orders
• Do everything in your power to limit the physical and financial impacts of your injuries

Mitigation is an important step in building a strong & honest case in your favor.

Consult with a JET 7 Injury Lawyer

Next, you should consult with an injury attorney to discuss your legal options. After consulting with at least one attorney, consider the benefits of hiring an injury lawyer to represent you in your JET 7 injury lawsuit.

You can get a free, no-obligation consultation from a THL attorney today.

Remember, the statute of limitations limits the amount of time you have to take legal action after an incident or injury, so do not hesitate to initiate the process and talk to a lawyer as soon as possible.

Hiring an attorney can be a strenuous decision and takes some diligent research. You should seek legal representation from a lawyer who:

• Has experience trying medical devices cases
• Has resources and firm support to build a strong case in your favor
• Has a winning history in the courtroom
• Is dedicated to getting you the best result possible

What will my attorney do?

An experienced personal injury attorney can help you in the process of building a strong case & then use his or her knowledge of the court system to litigate on your behalf.

Some roles of your attorney include:

• Gathering evidence to build your case
• Establishing liability for your injuries
• Assessing damages resulting from those injuries
• Navigating the complex civil litigation process
• Representing your interests to the courts
• Getting you compensated for your damages through a settlement or verdict

Your attorney will handle the ligation process so that you can focus on the most important thing, recovery.

How Much Does a JET 7 Catheter injury lawyer cost?

At TorHoerman Law, our attorneys operate on a contingency fee basis, meaning that we do not charge legal fees to our clients until after they have been awarded compensation for their JET 7 injuries.

If our clients are not compensated through a settlement or verdict, we foot the bill for all legal costs incurred. That’s right – if we don’t win your case, then you do not pay any legal fees. That is our way of guarenteeing to our clients that we only take cases that we believe we can win & that we are as committed as our clients to getting the best possible outcome from their case.