A catheter is a medical device, essentially a tube, used in a wide range of medical procedures. Certain catheters are designed to access veins and arteries. Vascular catheterization allows a physician to perform certain diagnostics that are otherwise impossible, such as sampling blood directly from the heart; measuring blood flow in the heart’s chambers; or evaluating blockages or abnormalities in the blood vessels outside the heart, such as the arms and legs.
From May 7, 2015 through March 31, 2017, Vascular Solutions, Inc., a subsidiary of Teleflex Incorporated, manufactured the Venture Catheter, a novel piece of medical equipment. The catheter had a specialized tip, which could be manipulated remotely and bent at an angle up to 90°. The controllable tip provided significant maneuverability for moving in and around tight spaces.
The Venture Catheter had fatal design flaws, however. There was excess material located at the tip of the catheter. The tip could split during a procedure. In more severe cases, pieces of excess material could break away and escape into the patient’s vascular system.
Having a free-floating foreign particle in the blood stream is extremely dangerous. The body’s natural response to having a foreign object in the body include activation of the coagulation system. Coagulated blood is extremely helpful in the process of sealing open wounds, but where a foreign body causes local inflammation, particularly along the blood vessel wall, it can activate endothelial cells, platelets, and leucocytes, triggering a hypercoagulation state. Coagulated blood can form into a blood clot.
A thromboembolism occurs where a blood clot traveling through the vascular system becomes lodged, blocking the flow of blood through the vessel. The catheter material itself can also block blood flow on its own, which is called a foreign body embolism. Whether the flow of blood is completely blocked or not, the health consequences are generally very serious. If the embolism affects the heart, it can cause a heart attack; if in the brain, a stroke; a blockage in the lung is called a pulmonary embolism; if it affects other peripheral locations in the body, it is called a tissue infarction.
Upon discovery of the dangerous defect, the United States Food and Drug Administration (“USDA”) issuing a “Class I” recall, halting production, distribution, and use of the catheter immediately. A Class I recall is employed where there is a “reasonable probability that use of [the medical device in question] will cause serious adverse health consequences or death.” This is the most urgent recall available to the USDA. As of the date of the recall, which was voluntarily undertaken, Teleflex claimed that there had been no reports of adverse events caused by use of the catheter.
Where a company designs a product in a manner that it makes its use so inherently dangerous that it outweighs any potential utility, a product liability case may lie. In some jurisdiction, a plaintiff can establish liability if it can be shown that the product poses a foreseeable danger when used as intended. In other jurisdictions, the plaintiff must then demonstrate that there was an alternative design that would have been safer without making its production and use economically and technically unfeasible. Once a defective design has been shown, the manufacturer—or any commercial actor in the stream of commerce selling the product—is liable for injuries resulting from its appropriate use.
If you or a loved one has experienced any of the above described effects from the use of a Venture Catheter, contact the experienced attorneys at Neumann Law for a consultation.