Doctors insert Beacon Tip Angiographic Catheters into blood vessels to check for blockages in blood flow to and from the heart. But Cook issued a worldwide recall for these catheters after it received reports of tips breaking and causing serious injuries that required medical intervention.
Doctors use Beacon Tip Angiographic Catheters in patients undergoing a cardiac angiogram. A cardiac angiogram is an invasive medical imaging procedure used to obtain pictures of the heart’s blood vessels. The purpose of the procedure is to enable treating physicians to detect any blockages, called occlusions, and abnormalities. Occlusions and abnormalities can cause problems with the amount of blood flowing to the heart. A cardiac angiogram is a common procedure and typically used for identifying coronary artery disease.
A cardiac angiogram has minimal side effects. However, individuals undergoing the procedure may have encountered unexpected medical complications because of Beacon Angiographic Catheters. On July 2, 2015, Cook Medical issued a global class I recall for these catheters because the tips may split leading to blockages in blood flow to organs. A class I recall is the most serious type of recall. This means the product involved in the recall may cause severe injury or death. It expanded the recall to a wider variety of catheters on October 7, 2015.
Medical complications caused by the catheters opened the door for lawsuits on behalf of patients.
What are Beacon Angiographic Catheters?
Beacon Angiographic Catheters are manufactured by Cook Medical of Bloomington, Indiana. The catheters in question were first placed on the market in 2013.
The Beacon angiographic catheters are thin plastic tubes with tips at the end of them. Cook Medical designed the catheters to be inserted into a patient’s vascular system during cardiac angiogram procedures. The medical professional’s using the catheters would use them in conjunction with a sheath introducer or wire guide.
Beacon Tip Catheters and Complications
The potential complication with the Beacon Tip Catheter is it can malfunction during a cardiac angiogram procedure. This malfunction can lead to serious injury or death for the patient undergoing the procedure.
Catheter Tip Separation and Splitting
Properly designed and manufactured catheters are supposed to remain in one piece throughout the procedure. According to the recall warning, these angiographic catheters made by Cook may split or have the tips separate from the rest of the device. The separated tip or part of the catheter may become stuck in the heart or move to other parts of the body. Medical intervention is needed to retrieve the separated part.
The tip of the catheter can enter the patient’s bloodstream. Once in the bloodstream, the patient becomes susceptible to serious injury or death. Another serious consequence is that fragments from the separated device may stop blood from flowing to organs.
How do Angiographic Catheters Work?
During a cardiac angiogram procedure, the patient receives a mild sedative to relax. However, the patient typically remains awake during the procedure. A cardiologist, or doctor performing the procedure, inserts a thin, long and flexible tube about 2 to 3 mm long into the patient’s wrist or groin area. The angiographic catheter is then guided into the patient’s heart. A cardiologist also uses a fluoroscope to produce X-ray images.
Once theangiographic catheter is inside the heart, a fluorescent dye is injected into the area via the catheter. More X-ray images are taken. These images capture how the dye moves throughout the patient’s coronary arteries. Each dye injection is repeated in each of the patient’s major coronary artery and branches.
After the images are taken, the cardiologist will gently remove the angiographic catheter.
Types of Angiographic Catheters
Angiography is a type of technique used to obtain images of blood vessels. Cardiologists choose the type of angiographic catheter to use during the procedure. The types of angiographic catheters vary in size, shape and design.
The types of angiographic catheters available include:
Guide Catheters: The guide catheters have reinforced construction. The angiographic catheters also have a stiffer tube to provide back-up support when inserting stents, guide wires and balloons.
Diagnostic Catheters: These catheters are braided and have a soft tip attached.
Vascular Catheters: Vascular catheters can be guided or diagnostic. Both catheters have numerous head shapes a cardiologist can use depending on need and procedure.
Torquability: These catheters are designed for maneuvering and responsiveness at the hub.
Pushability: Pushability >catheters’ description is based on the cardiologist being able to apply force at the hub to move the edge of the catheters forward.
Trackability: These catheters have the ability to follow a guide wire around corners and through winding blood vessels without having to remove the wire.
In addition to the types of catheters listed above, the tips of the devices determine the function. Catheter head shapes vary from simple to complex and include:
- Double curve
- Reverse curve
- Simple curve
- Complex curve
Adverse Reports and Recalls
An adverse event is a medical term used to describe complications or side effects associated with the use of medication or medical device. Adverse events include:
- Permanent damage
Health professionals typically make adverse reports to the manufacturer or FDA.
Prior to the Cook Medical’s voluntary recall, it received 26 reports of the catheters malfunctioning. Approximately 14 of the malfunctioning catheters generated 14 adverse reports.
Cook Medical indicated that the recall was a class I, the most serious. This means there’s a reasonable chance that using the angiographic catheters will have serious health consequences or death for a patient.
On July 2, 2015, Cook Medical announced a voluntary recall of lot-specific units of Beacon Tip Angiographic Catheters. A voluntary recall is a request by the manufacturer to have its product pulled from the market. In a letter to customers, the company instructed customers to immediately quarantine any unused angiographic catheters from their inventory and promptly return all unused angiographic catheters back to Cook Medical.
In October 2015, Cook Medical expanded its’ voluntary recall of the angiographic catheters. At the time of this updated recall, the company received 42 medical device reports. These products included:
- Torcon NB Advantage Beacon Tip Catheters
- Royal Flush Plus Beacon Tip High-Flow Catheters
- Slip-Cath Beacon Tip Hydrophilic Catheters
- Shuttle Select Slip-Cath Catheters
The current voluntary recall includes 2,239 lots of Beacon Tip Angiographic Catheters distributed from June 2013 to June 2015. The voluntary recall also includes select sizes of the Beacon Tip Angiographic Catheters.
Manufacturer Negligence & Lawsuits
When a manufacturer’s failures to prevent harm to an individual, it’s called negligence. In this situation, Cook Medical may be negligent because its’ catheters are considered defective. The voluntary recall of the Beacon Tip Angiographic Catheters may allow harmed patients to file lawsuits. Potential personal injury lawsuits could involve manufacturer’s defect or failure to warn about the product’s danger.
A personal injury lawsuit settlement or verdict will reimburse a patient for any additional medical bills and damage that resulted from the device mitigation. A wrongful death lawsuit can be filed on behalf of an individual who died because of catheter failure.