When catheters break or malfunction, a patient may suffer serious if not fatal injuries. Unfortunately, millions of catheters have been recalled over the past few years due to defects and malfunctions. Thousands of adverse event reports have been filed with the FDA showing that some of the most common injuries sustained are also the most severe such as:
- Blood clots
- Heart attack
- Internal organ damage
- Emergency surgeries
- Wrongful death
Thousands of Catheter Adverse Events Filed with FDA
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If a catheter breaks while being used, pieces of the device can travel throughout the body causing injuries and severe complications. Included in the thousands of adverse event reports filed with the FDA are cases of permanent injuries and death. When the use of a medical product could result in severe or permanent injury or death of patients, the FDA will issue a Class 1 recall, the agency’s most severe type of recall.
Over the last ten years, more than 5,000 adverse event reports have been filed over catheters that got stuck during a procedure or broke during use causing pieces to migrate through the body. At least six Class 1 catheter recalls were issued in 2017 alone involving thousands of catheters, some of which caused patients severe injury or death.
Some of the health consequences that can occur if a catheter breaks or malfunctions while being used 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
Catheter Class 1 Recalls
When catheters malfunction, a whole host of problems may arise. For example, three Class 1 recalls were issued after it was discovered that physicians could have trouble removing the sheath from certain Abbott Vascular catheters used during cardiac procedures. The FDA said in the recall notice that this problem could cause the device to fail to inflate and deflate properly and lead to patients suffering myocardial infarctions, air embolism, and thrombosis. Another recall was initiated after reports that the mandrel of the catheter could fracture and cause serious injury. One death was reportedly caused by the problem.
Five Class 1 recalls were issued by Boston Scientific Corp after it was learned that the catheters could break during use and require the patient to undergo additional procedures to retrieve and remove device fragments so the blood supply to the heart would not be interrupted. Physicians reported the problem caused catastrophic vessel damage and at least three patients died in connection with the issue.
Balloon catheter kits made by Arrow International were recalled after it was discovered that during a procedure, the sheath of the catheter could break away from the device and result in the patient suffering significant blood loss. In fact, at least 13 patient injuries were reported including the death of one patient.
Thousands more catheters have been recalled because of dangerous defects that can cause deadly patient injuries. From faulty valve seals that can cause blood loss and air embolism, to tips that break off, shafts that fracture, and excess material that splits from the device to enter the bloodstream, these defective medical devices have been used in medical facilities across the country, putting the lives of countless patients at risk.
Any person who suffers injury because of a defective, malfunctioning or broken catheter may be entitled to hold the device manufacturer liable and seek compensation for their injuries. If you were injured or if your loved one suffered a fatal injury, we urge you to contact us today to learn more about your rights and if you are eligible to seek justice for your injuries and compensation for your losses.
A thrombectomy is a procedure in which blood clots from the coronary arteries or peripheral veins are removed. Typically, this procedure is only performed when there is a significant risk of a blood clot breaking free and traveling through the body where it can cause heart attack, stroke, or a blockage in the lung. Unfortunately, the Fetch 2 Aspiration catheters made by Boston Scientific used in these types of procedures were breaking in several places resulting in device fragments entering the patient’s bloodstream. Pieces of the catheter were easily removed from some patients; however, other patients were forced to undergo surgery for the fragments to be retrieved and removed. All in all, more than 21,000 catheters were recalled in a Class 1 recall.
The medical device manufacturer had to issue a worldwide recall for the Lotus transcatheter aortic heart valve replacement system after it was learned that the release mandrel could break while the valve was being implanted. Surgeons were forced to try to remove the fragments, but in three cases the patient suffered catastrophic vessel damage and died.
Boston Scientific then had to recall the Lotus heart valve replacement system after it was discovered that the deployment tool pin disconnected before the surgeon was ready to release the device. The worldwide recall was issued after a patient died from aortic dissection during a second implantation attempt. In another case, doctors were able to secure the prematurely released valve but were not able to remove it from the patient.
Catheters that break or malfunction may also cause the patient to suffer embolism. In fact, when Edwards LifeSciences pulled their Certitude Delivery System from the shelves of medical facilities across the country, they notified the facilities that the device had a defect that could cause patients to suffer embolism.
The Certitude Delivery System is used during heart valve replacement procedures. Surgeons attach the replacement heart valve to a small balloon catheter and guide it with the Delivery System through the chest and into the aortic valve of the heart. Then the balloon is inflated to set the valve into place. The device makers had to pull the device because an overflow of molding material remained on the devices. This material could separate from the catheter during a procedure, and travel through the circulatory system and cause an embolism – the blockage of an artery.
The FDA reported that the defect could block blood flow from critical organs and lead to severe injury. The agency deemed this a Class 1 recall because a patient may need to undergo additional procedures to remove the overflow material from the body and in a worst-case scenario, the defect could cause permanent renal, cardiac, gastrointestinal, or neurologic damage.
Catheter migration involves pieces of the devices traveling from their intended position to elsewhere in the body, sometimes causing serious injury. For example, Cook Medical initiated a recall of catheters, and within the same year expanded the recall list to include over 400,000 catheters. The following year, the company expanded the recall again to include over four million catheters, all made with Beacon Tip Technology. The catheters were used for various procedures including liver biopsies, medical device introducers, installing contrast media into the body, and for peripheral and coronary vascular angiography procedures, among other uses.
After investigating the problem, Cook reported the catheter Beacon Tip showed signs of polymer degradation which was causing the tip to detach from the device. At least 30 medical device reports were filed with the FDA over the issue. The tip detachment could cause the device to fail and result in serious and life-threatening complications. If the tip detached during a procedure, it could travel to the genitourinary or vascular system or enter the circulatory system and block blood flow to the lungs, the heart and other vital organs.
Intra-Aortic Balloon Catheters are used to restore blood flow through the coronary arteries and work by inflating and deflating the balloon with the patient’s heartbeat. To implant the device, surgeons slide a long, thin, flexible catheter in through the femoral artery in the leg up to just below the heart in the center of the aorta. However, manufacturer Arrow International had to recall the devices after the FDA received 13 adverse event reports of serious injury and at least one patient death. Several product lots were included in the recall after it was discovered that the sheath used to guide the device through the body could separate from the catheter hub. The malfunction could cause the patient to experience profound or fatal bleeding.
Reflow recalled the Wingman 35 Crossing Catheter in a Class 1 recall after it was discovered that the tip of the catheter could separate or split off from the device while inside a patient. The device is used to administer fluids and medications and to access arteries and veins. If the tip breaks free from the catheter, it could enter the patient’s bloodstream and cause severe health consequences such as heart attack, vessel damage, blood clots, embolism, and death.
We Can Help
Many patients are unaware of the laws that protect them from defective devices, and most don’t know what type or brand of catheters are used during their procedures. That’s where we come in.
If you suffered additional surgeries or other adverse event or health complication from a defective or recalled catheter, contact us now. We can find out what brand of catheter was used in your treatment as well as how it was used. We can determine if your complications were caused by a defective catheter and whether you are entitled to seek justice for your injuries.
For decades we have fought for the rights of patients harmed by the medical devices that were supposed to help, and we stand ready to fight for you today.
Contact us today to learn more about patient rights and if you are eligible to seek significant financial compensation for your injuries.