Did You or a Loved One Suffer Injury From a Defective Catheter?
Table of Contents
- 1 Did You or a Loved One Suffer Injury From a Defective Catheter?
- 2 Catheters Causing Serious and Fatal Injuries
- 3 What’s the Problem with Catheters?
- 4 FDA Issues Class 1 Recalls for Dangerous Catheters
- 5 Catheter Breakage Results in Severe Injury and Death
- 6 Migration of Catheter Fragments Can Damage Organs
- 7 Catheters That Cause Embolism
- 8 When Catheters Cause Profound Blood Loss
- 9 We Can Help
Catheters used in medical procedures may break and can migrate through the body. If you’ve been injured by a defective catheter, you may be entitled to significant compensation.
Catheters Causing Serious and Fatal Injuries
Thousands of adverse event reports have been filed with the FDA over potentially defective catheters. Patients are being seriously injured and even killed when catheters used during surgical procedures break or separate and travel through the blood stream to damage organs and cause serious injuries.
Some of the most common injuries reported in catheter adverse events include:
- Heart attack
- Blood clots
- Organ damage
- Emergency surgery
What’s the Problem with Catheters?
Millions of catheters are in use at any given moment in the U.S. They are used for a multitude of reasons, but many of those under recall are used for medication administration, injecting contrast dyes, and removing small blood clots from arteries and veins. However, many adverse event reports claim that catheters are not functioning properly, not draining fluids, or not administering medicines and fluids in the proper way, causing significant health problems.
In fact, more than 5,000 adverse events reports have been recorded over the last ten years, including reports of catheters breaking, getting stuck, and migrating, causing patients serious harm and even fatal injuries. Some of the consequences resulting from malfunctioning catheters include:
- Blood clots
- Air embolism
- Catastrophic vessel damage
- Prolonged hypertension
- Organ damage
- Profound loss of blood
- Low cardiac output
- Delay of life-saving treatment
- Cardiopulmonary arrest
FDA Issues Class 1 Recalls for Dangerous Catheters
Class 1 recalls are the most severe type of recall issued by the U.S. Food and Drug Administration. They are used in situations where the agency believes there is a risk that use of the product will cause serious injury or death. Six Class 1 catheter recalls were issued in 2017 alone, involving hundreds of products.
10/25/17 – Class 1 Recall: OriGen Biomedical Medical Reinforced Dual Lumen ECMO Catheter – Used in patients undergoing life support procedures like cardiopulmonary bypass surgery, the catheter was recalled because of the extension tube may separate from the hub connection, which can cause serious injury including loss of blood, prolonged hypotension, low cardiac output and cardiopulmonary arrest.
9/25/17 – Class 1 Recall: Spectranetics Corp. Bridge Occlusion Balloon Catheter – Used in lead extraction surgeries, the catheter was recalled because some device units may have a blocked guidewire lumen which could cause the device to be improperly positioned and unable to control hemorrhage, delaying life-saving treatment that may result in serious injury or death.
6/22/17 – Class 1 Recall: Teleflex’s (TFX) Vascular Solutions, Inc. Venture® Catheters – designed to steer, control, and support a guide wire, the recall was initiated due to the possibility of the tip separating during use, allowing excess material to migrate, which could cause serious injury including embolism.
6/21/17 – Class 1 Recall: Vascular Solutions Inc. Venture Catheters – Designed to steer, control, direct, and support guidewires when accessing arteries and veins in the heart muscle, arms or hands, feet or legs, and to administer fluids or medications into the blood, the recall was initiated due to risk of catheter tip splitting or separating during use, potentially allowing excess material at the top to enter the bloodstream, which can cause serious injury, including blood clots, embolism of the material to vital organs, and death.
5/19/17 – Class 1 Recall: Abbott Vascular Coronary Catheters – used in cardiac procedures involving balloon dilation. Recalled after 19 reports of patient injury and one report of death due to issues removing the protective balloon sheath, which can cause serious injury, including air embolism, heart attack, arterial clots, and death.
5/15/17 – Class 1 Recall: ReFlow Wingman 35 Crossing Catheters – used to access veins and arteries and administer medicines or fluids, the recall was initiated due to the catheter tip separating or splitting during use, which can cause serious injury, including damage to the walls of the blood vessel, the development of clots, embolism, heart attack and death.
Millions more dangerous catheters made by many different manufacturers were recalled during 2015 and 2016.
Catheter Breakage Results in Severe Injury and Death
If there is a great chance of blood clots deep in the coronary arteries or peripheral veins dislodging and causing stroke, heart attack, or pulmonary embolism, you may have to undergo a procedure called a thrombectomy to remove the clots.
The Fetch 2 Aspiration Catheter by Boston Scientific was used in thrombectomy procedures until it was discovered that the catheter could break in several places while being used causing pieces of the device to enter the bloodstream. More than 21,000 of these catheters had to be pulled from the market in the Class 1 recall. In some patients, the catheter fragments were easily recovered, but other patients had to undergo surgery to locate and remove them.
But this wasn’t the first problem Boston Scientific had with its products. The company had to issue a worldwide recall of a catheter used in aortic heart valve replacement procedures after it was discovered that while the valve was being replaced, the mandrel that releases the valve could break allowing fragments to escape. Surgeons would then have to try to retrieve the pieces of the Lotus valve system before they could cause damage, but catastrophic damage to the vessels resulted in the deaths of three patients.
A second worldwide recall was issued for the device after a patient died from aortic dissection when a pin in the deployment tool disconnected too soon forcing the surgeon to try a second attempt. Physicians were able to secure a prematurely released valve in a different patient, though they were unable to remove it from the body.
Migration of Catheter Fragments Can Damage Organs
The consequences of a piece of catheter migrating through the body depend on what the device is being used for. When Cook Medical learned that the tips of certain catheters were breaking off while being used, the company initiated a recall. Within months, the company expanded the recall to include over 400,000 catheters. The company expanded the recall again after learning that all catheters that had a Beacon Tip were prone to break. More than four million catheters were pulled in the Class l recall.
Cook Medical investigated the breakage issue and determined that catheters with Beacon Tips showed a degradation of the polymer resulting in tip detachment. The FDA received at least 30 medical device reports over the issue.
The devices were used for a wide variety of purposes including as medical device introducers, liver biopsies, to see inside the peripheral veins and coronary arteries, and to inject contrast dyes into the body, among many other uses. The FDA reported that a detached catheter tip could result in patients suffering serious and potentially life-threatening consequences such as the tip traveling through the circulatory system to block blood flow to the heart, lungs, or brain, or entering the vascular or genitourinary system where organ damage could occur.
Catheters That Cause Embolism
An embolism is a blockage of an artery, typically due to foreign matter, an air bubble, or blood clot in the vessel. Catheters are often used to help surgeons remove dangerous blood clots from the arteries and veins. But what happens when the catheter causes an embolism?
The Certitude Delivery System was recalled from the market after facilities that used it started filing reports with device maker, Edwards LifeSciences, that the device was causing patients to experience embolism. The system is used to replace heart valves and contains a small balloon catheter that used to guide the replacement valve to the heart. Once in place, the balloon is inflated to secure the valve to the aorta.
However, the FDA reported that excess molding material used to make the device could remain on the system and detach during use. These material fragments could travel through the body and block blood flow to critical organs resulting in severe and potentially life-threatening consequences. The government agency issued a Class 1 recall for the devices due to the risk of severe or fatal injury and reported that a patient might need to undergo additional surgeries to locate and remove the material. Health consequences that could be suffered by a patient due to the excess material include permanent cardiac injury or renal, neurologic, or gastrointestinal damage.
When Catheters Cause Profound Blood Loss
A Class 1 recall was initiated for Arrow International Intra-Aortic Balloon Catheters after a dangerous malfunction was reported. The device is used to restore the normal flow of blood through the coronary arteries in patients who have failing hearts or insufficient blood flow. The device is slid through the femoral artery and situated in the aorta where the balloon inflates and deflates with each beat of the heart. However, the Teflon cover of the device could detach from its hub and cause severe and profound bleeding. At least 13 adverse event reports were filed with FDA including reports of six patients being seriously injured and one patient dying because of the defect. More than 47,000 units were recalled from medical centers, hospitals, and clinics worldwide.
We Can Help
If you or a family member suffered serious injury, including clots, blood vessel damage, embolism, heart attack, or if your loved one died because of a catheter breaking or pieces migrating to other areas of the body, you may be entitled to significant compensation for your injuries and losses.
For decades, we have fought for the rights of patients harmed by defective devices and dangerous medications and we stand ready to fight for you now. Contact us today to learn more about how we can help and if you are entitled to compensation.