JET 7 Catheters

The Penumbra JET 7 Xtra Flex and Penumbra JET 7 MAX catheters were designed to remove blood clots and were approved by the FDA in 2019 and 2020. The FDA received over 200 reports of failures with these catheters. These reports included reports of the tips of the catheters expanding or breaking. As a result, there was an increased risk of death or injury.

 

In July of 2020, the FDA issued a warning regarding the JET 7 MAX and JET 7 Xtra Flex catheters, updating its labeling to reflect the risks. The FDA also instructed Penumbra to issue a notice to healthcare providers regarding the warnings about the catheters.

 

In December of 2020, Penumbra issued a voluntary recall of all JET 7 Xtra Flex and JET 7 MAX catheters. More than 30,000 of these catheters were distributed to healthcare providers, who now have to quarantine the devices and then send them back to Penumbra. This recall comes five months after the initial warning issued by the FDA. Before the FDA issued its July warning, 14 people had died and more had suffered from an injury, including from cerebral infarctions, vessel damage, and hemorrhages.

 

If you or a loved one has suffered from a blood clot and the JET 7 MAX or Xtra Flex catheter was used to remove the clot and as a result, you suffered from health complications or a loved one suffered a wrongful death, you may have a case against Penumbra. Contact Farah & Farah for a free consultation. You pay nothing unless your case is successful.

 

What Is a Catheter?

A catheter is a thin tube that is inserted into a person’s body for medical purposes, including draining fluids, administering medication, and aiding in surgery. Catheters are typically thin and flexible but can vary in stiffness, depending on the medical need. These medical devices can either be temporary or permanent.

The History of Catheters

Catheters have a long history. They were used as early as 3,000 BCE in ancient civilizations such as ancient China, Rome, Greece, Syria, and India. In ancient China, onion stalks were used, while the ancient Greeks, Romans, and Hindus used tubes made out of either metal or wood. The word catheter actually comes from Ancient Greek for “to let down” and originally was used to indicate an item that was inserted somewhere.

 

Benjamin Franklin is among the famous historical figures known for having made catheters. He created some from silver for his brother, John, who needed them for treating his kidney stones. Franklin created flexible silver catheters so his brother’s daily need to insert a catheter into his bladder would be less painful.

The Uses of Catheters

Catheters have a variety of uses in many different medical procedures. Typically, they’re used to either insert something, which can include medication or a surgical device, into a person’s body or to drain something out of a person’s body. One of the most common types of catheter is a urinary catheter. Urinary catheters are used to drain urine from a person’s bladder (or another part of the urinary tract) if the person is unable to control their own bladder. Intravenous catheters are used for providing blood or medication to patients and are more commonly known as IVs.

Types of Catheters

There are a variety of different types of catheters, each with different purposes. Urinary catheters have four primary types:

• Foley catheters
• Intermittent catheters
• Condom catheters
• Suprapubic catheters

Intravenous catheters, by contrast, have two primary types:

• Central venous catheter
• Peripheral venous catheter

There are also catheters that are used to allow surgical instruments into the body during surgery.

 

Catheters can be made out of the following materials:

• Plastic
• Latex
• Silicone rubber

Foley Catheters

Foley catheters are meant to be longer-lasting. One end is inserted into the bladder and the other drains urine out into a bag that needs to be emptied whenever it’s full. Although meant to stay rather than constantly being removed and replaced, Foley catheters do need to be replaced every three months.

Intermittent Catheters

An intermittent catheter is so-called because it is used only intermittently. It’s designed to be inserted into the urethra in order to drain the urine out of the bladder. Patients who have been prescribed an intermittent urinary catheter insert it when it’s needed, but then remove the catheter afterward.

Condom Catheters

Condom catheters are similar to their namesakes in that they are designed as sheaths that are similar in material and appearance to condoms. These are usable by some men instead of a more invasive catheter. The catheter’s sheath covers the man’s genitalia and then a catheter tube drains urine from the sheath into a bag. Although these are often more comfortable, there’s a greater risk of the catheter slipping and leaking.

Suprapubic Catheters

A suprapubic catheter is a type of catheter that a doctor inserts directly into the bladder via a cut in the abdomen, just below the belly button.

Central Venous Catheter

A central venous catheter is a type of intravenous catheter, or IV. This type of catheter is meant for long-term use and can stay inserted for months or even years. These catheters are inserted into one of the large veins that connect directly to the heart via the neck, chest, arm, or leg. Central venous catheters are used for those who need medicine through an IV for a longer period of time.

Peripheral Venous Catheters

Peripheral venous catheters are typically connected to veins in the foot, arm, or hand. This is the type of IV most commonly seen in movies and TV.  They’re used when someone needs medicine, fluids, or blood on a short-term basis. A peripheral venous catheter can stay inserted for up to four days before it needs to be replaced.

How Does a Catheter Work?

Catheters work by connecting a vein or organ in the human body to a container. For example, in a urinary catheter, one end of the catheter is connected to the bladder or the urethra, depending on the type of catheter, and the other end is connected to a bag that will hold the urine that is drained. In an IV, the catheter connects the patient’s vein to a bag containing the blood, medicine, or other fluid that the patient needs.

 

All catheters work by connecting a part of the body to a container. The different types of catheters vary in where they’re inserted, what is in the container they’re connected to, and whether they’re draining or inserting.

What Complications Can Catheters Cause?

The possible complications that can arise from a catheter depend on what kind of catheter it is. The complications of urinary catheters can include:

• Infections:
  • Kidney
  • Blood
  • Urinary tract
• Bladder stones
• Injury to the urethra
• Kidney damage
• Bloody urine
• Bladder cancer
• Leaks

 

The complications that can arise from intravenous catheters can include:

• Vein injury
• Blood leaking
• Collapsed lung
• Heart rhythm changes
• Clotted blood blocking the catheter
• Infection in the skin
• Blood clot

For an IV, many of these potential complications, such as leaking blood, solve themselves with time. Others a doctor or nurse may have to address.

What Is the JET 7 Catheter?

The JET 7 catheter is a type of catheter designed for use in revascularization procedures. Revascularization is the process of restoring the passage of blood through a part of the body where a medical event such as a clot caused the blood flow to be restricted. The catheter attaches to a vacuum that sucks out blood clots through the catheter and into the vacuum’s container.

Who Makes the JET 7 Catheter?

The JET 7 Catheter is produced by the company Penumbra. Penumbra is an international healthcare company that has its headquarters in California. The company’s stated purpose is to design innovative and novel products, especially in order to meet existing medical needs or gaps. The company received FDA approval in June 2019 for its JET 7 Xtra Flex catheter and in February 2020 for its Jet 7 MAX catheter. However, both types of catheters were urgently recalled in December of 2020 due to complications and some deaths. The JET 7 catheter with the standard tip is unaffected by these issues and has also not been recalled as a result.

What Is a Blood Clot?

A blood clot is a gel-like clump of blood that forms in a vein, blocking the passage of blood. Blood clots are beneficial when they form at the site of a cut or other injury because the clot is what prevents the affected person from bleeding out. However, they can also form within the veins rather than at the site of an injury. These internal blood clots can obstruct the flow of blood, especially if they are located in the legs or another critical area that contains a major artery leading to the heart. This type of blood clot may require medical attention in order to remove it as it won’t dissolve on its own.

Blood Clot Causes

There are a variety of different causes for a blood clot. They can be caused by some medications,  certain health conditions, and health events such as a heart attack. The causes of a blood clot can include:

• Stroke
• Surgery
• Pregnancy
• Heart attack
• Obesity
• Deep vein thrombosis
• Family history of having blood clots
• Peripheral artery disease
• COVID-19
• And more

Blood Clot Symptoms

It may be possible for a blood clot to clear on its own. However, many do require medical attention to remove. A patient should consult with a doctor if experiencing any of the following symptoms in an area on an arm or leg:

• Pain
• Redness
• Swelling

A patient should seek emergency medical attention immediately if experiencing any of the following symptoms:

• Lightheadedness
• Chest pain
• Chest tightness
• Rapid heartbeat
• Cough producing sputum (mucus)
• Difficulty breathing
• Painful breathing
• Pain in the arm, shoulder, and lower jaw
• Weakness in the arm, leg, or face
• Numbness in the arm, leg, or face
• Changes in vision
• Aphasia (difficulty speaking or understanding the speech of others)

Methods to Avoid a Blood Clot

While some blood clots may be unavoidable, there are some measures people can take to reduce the risk. These actions include:

• Moving if you’ve been sitting for long periods of time
• Avoid sitting for long periods of time
• Drinking lots of fluids when sitting for long periods of time is unavoidable, such as during travel
• Lifestyle changes:
  • Quitting smoking
  • Exercising regularly
  • Losing weight
  • Lowering high blood pressure

How Does the JET 7 Catheter Remove a Blood Clot?

The JET 7 catheter removes a blood clot by connecting a vacuum to a catheter. The catheter is placed inside the patient’s body at the site of the clot and the vacuum sucks the clot through the catheter in order to remove it. The catheter can be used in conjunction with a revascularization device, which is made up of four intraluminal chambers that can trap the clot so it’s easier to remove. Intraluminal in this case means inserted within the veins itself because the revascularization device is connected to the catheter on the end inserted into the vein and traps the clot so it can be sucked into the catheter more easily.

JET 7 Catheter Complications

In addition to the normal potential complications that are present with the usage of a catheter, the Penumbra JET 7 catheter additional complications. After the devices received FDA approval in 2019 and 2020, the FDA continued to monitor them and received reports of 14 cases of deaths and other cases of the following injuries:

• Vascular trauma
• Hemorrhages
• Cerebral infarctions

Vascular Trauma

Vascular trauma is damage to the blood vessels. When the blood vessels are damaged, other, more serious health conditions can potentially occur. Blood vessel damage can cause health issues such as:

• Heart attack
• Stroke
• Vision loss
• Blindness
• Kidney disease or failure
• Erectile dysfunction
• Weakened immune system
• Increased risk of infections
• Poor circulation
• Nerve damage
• Slow healing of wounds

Hemorrhage

A hemorrhage is another word for blood loss. It can be used to refer either to blood loss that occurs internally or to external blood loss. Blood can be lost almost anywhere in the body and may or may not be obvious. External bleeding is more obvious when it comes from an open wound or from a natural opening in the body such as the mouth. However, bleeding can also occur internally if there is damage to a vein and is more difficult to detect. It’s this type of bleeding that is most likely to occur from usage of a JET 7 Xtra Flex or MAX catheter because the failure involved with those types of catheters stems from the expansion or breakage of the tip inside the body.

Cerebral Infarction

A cerebral infarction is another name for a stroke. A stroke occurs when a patient suffers from a lack of oxygen to a part of the brain. This area within the brain suffers damage as a result because the issues in this area die due to lack of oxygen. The symptoms of a stroke can include:

• Difficulty speaking
• Difficulty understanding what other people say
• Paralysis in the arm, leg, or face
• Numbness in the arm, leg, or face
• Headache
• Difficulty seeing out of either one or both eyes
• Difficulty walking

Penumbra JET 7 Catheter Recall

As of December 2020, Penumbra has issued an urgent voluntary recall of all JET 7 MAX and JET 7 Xtra Flex catheters. There are three different product numbers affected by the recall. This recall occurred because the FDA reported to Penumbra in July of 2020 that it had received more than 200 reports of the tip of the catheter either expanding or rupturing. The FDA at that time also updated its labeling of the affected catheters to reflect its warnings about the medical devices.

 

Health professionals who have any of the affected JET 7 catheters in their profession have been instructed to quarantine the devices and ship them back to Penumbra. This recall includes only JET 7 catheters with the MAX or Xtra Flex tips, not the Penumbra JET 7 catheters with the standard tips.

FDA Warnings about the Penumbra JET 7 Catheter

The FDA issued a warning to Penumbra about the reports they were receiving regarding an increased risk of death for patients using the device. This warning required Penumbra in July 2020 to notify healthcare providers with information regarding the new warnings. The FDA also updated its labeling of the device to include the new warnings.

Should I Consider a Penumbra JET 7 Catheter Lawsuit?

The JET 7 Xtra Flex and JET 7 MAX catheters were recalled because the tips enlarged or broke while inserted in a patient’s veins. This failure of the catheter tip can cause hemorrhages, blood vessel damage, a stroke, or even death. In fact, the FDA received reports of 14 people who died as a result of damage from a JET 7 MAX or Xtra Flex catheter. Overall, the FDA received 200 reports of health damage from the catheters’ failure.

 

If you or a loved one has suffered from a blood clot that was treated with a JET 7 MAX or Xtra Flex catheter and suffered from health complications or wrongful death as a result, you may have a case against Penumbra. The company sold 30,000 units of these catheters to medical professionals for use in removing blood clots, and as a result, some patients were harmed, and 14 died. If you or a loved one was harmed by the use of Penumbra catheters, you may be eligible for compensation.  Farah & Farah’s team of highly skilled attorneys is experienced in handling lawsuits against the companies that manufacture faulty medical devices. Contact us today for a free consultation. You won’t have to pay anything unless your case is successful.