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The Beacon Catheter injury attorneys at the Drug Law Center can file a lawsuit on your behalf if you have been injured from Cook Medical’s failure to properly warnd you of the risks associated with the defective design of their products.
In April 2016, Cook Medical initiated a worldwide voluntary recall on over 4.1 million catheters because of complaints of the catheter tip fracturing or splitting. The technology of the Beacon Tip Catheter was found to shows signs of polymer degradation that resulted in a separation or fracture of the tip, which was causing significant injury to patients undergoing procedures.
Recurrent Fracturing and Splitting Complications
This is not the first time Cook Medical has recalled their catheters. In 2015, the catheter manufacturer recalled four specific French products lots that were manufactured during a specific time frame due to the same fracturing and splitting problem. The 2015 and 2016 recalls have involved numerous catheters manufactured by Cook Medical under varying company names and brands including Beacon Tip that can be identified by lot numbers. The brands and names of the catheters that have been recalled include
- Torcon NB Advantage Catheter
- Royal Flush Plus High Flow Catheter
- Centimeter Sizing Catheter
- Vessel Sizing Catheter
- White Vessel Sizing Catheter
- Selective Salpingraphy Catheter with Beacon Tip
- Shuttle Select Slip-Cath
- FluoroSet Radiographic Tubal Assessment Set
- Kumpe Access Catheter
- Aprima Access Nonvascular Introducer Set
- Liver Access and Biopsy Needle Set
- Transluminal Biliary Biopsy Forceps Set
- Neff D’Agostino Percutaneous Access Set
- White Lumax Guiding Coaxial Catheter
Angiographic Catheter Types
Based on angiographic testing requirements by the cardiologist, the radiologist or technician will use various techniques to obtain blood vessel images. Each available technique requires angiographic catheters that vary in design, shape, and size. These include guided, diagnostic, vascular, push-able, trackable, and torque-able catheters.
- Guide Catheter – Using a reinforced construction, guide angiographic catheters provide essential backup support using a stif tubing material when inserting balloons, guide wires, and stents.
- Diagnostic Catheter – Utilizing a soft tip, these catheters have a braided design and are manufactured for diagnostic purposes.
- Trackable Catheter – This catheter is designed to allow the technician to track the product’s guidewire around whining blood vessels and corners without the need to remove the guidewire.
- Push-able Catheter – The cardiologist can apply significant force to the hub of the device to push the catheter’s edge forward
- Torque-able Catheter – This catheter has increased torque-able responsiveness for easy maneuvering.
- Vascular Catheter – Used as a diagnostic tool, this catheter is available in varying head shapes for different procedures that meet the cardiologist’s needs.
How Beacon Catheters Work
The Beacon Tip Angiographic Catheter is a plastic tube that is used by medical professionals to prepare a heart for a cardiac angiogram to diagnose some heart conditions. Once the minimally invasive device has been guided through a small incision in the skin to a designated area a technician injects low-dose ionizing radiation contrast dye into the patient’s heart blood vessels.
Images of the ionized dye can be captured in x-ray, MRI and CT Scan imaging to produce accurate, clear and detailed pictures of the patient’s blood vessels. The process is often the best alternative to surgery to detect and identify body abnormalities like plaque (atherosclerosis and aneurysms), congenital heart disease, pulmonary embolism, and aorta splitting/dissection.
These procedures that capture imaging are used in crucial areas of the patient’s boy that include:
- Abdomen to view the liver or kidneys
- Feet and legs
- Hands and arms
The imaging capturing procedure using ionized contrast dye works similarly to traditional x-rays, CT scans, and MRIs. To maximize imaging results, the radiologist technician, nurse, or doctor will insert an IV (intravenous) line into the patient’s groin area after it has been shaved and numbed using local anesthesia. After insertion, the radiologist will guide The Beacon Tip catheter to the area of the body under examination before taking several sets of imaging. At this stage, the catheter will be removed and the technician applies pressure to the incision site or uses a closure device to begin healing the incision.
The results of the imaging are usually conducted by a specifically trained physician or radiologist who can interpret the examination by analyzing images.
Angiographic Catheter Adverse Risks
Individuals suffering from impaired kidney function, especially diabetic patients, are not considered to be ideal candidates for undergoing the procedure. Additionally, individuals who are known to be allergic to x-ray contrast materials might have a risk of suffering a reaction because the material contains iodine. Patients who have no other option than to undergo angiography might consider taking precautionary steps to decrease the potential of allergic reactions. This includes asking to use contrast material that does not have iodine or possibly receiving one or more dosages of a steroid drug prior to undergoing the procedure.
There are also other significant risks that include:
- The potential of developing cancer due to the excessive exposure to the product’s radioactive properties.
- Contrast material leakage at the IV incision site causing skin damage.
- Typical problems associated with taking x-ray images while the patient is pregnant.
- Breastfeeding a newborn or toddler after receiving radioactive intravenous contrast products.
- Iodine-associated allergic reactions.
- Temporary or permanent kidney damage associated with kidney disease and diabetes when using contrast material.
- Arteries punctured by the catheter causing internal bleeding.
- Catheter fracturing or splitting defects.
Any side effects or adverse reactions that arise can cause significant complications that could involve death, hospitalization, or permanent damage to an organ, arteries, or skin.
Cook Medical Beacon Tip Catheter Recall
In May 2016, a global voluntary recall was initiated by Cook Medical to pull 4.1 million units of its Beacon Tip Technology out of the medical marketplace. First developed in the 1990s, this catheter device uses a tungsten-loaded radiopaque tip that can separate or fracture from polymer degradation. Some products were recalled in 2015 to ensure patient safety after the company received an increasing number of complaints. At first, the company recalled 408,000 catheters (4-F lots) because some had fractured or split. By mid-April 2016, Cook Medical recalled every size and lot of Beacon Tip Catheters.
President of Cook Medical and Cook Group Pete Yonkman stated that the company has “been investigating a variety of factors including environmental influences, and it has been difficult for us to reproduce the exact failures …” The Company President also stated that “if we cannot tell our customers how to keep our product safe, then we are not comfortable leaving them on the market. It is a risk we are not willing to take. Patient safety comes first – period.”
Cook Medical has increased the production of their catheters that are manufactured without the tungsten loaded tip. In addition, the Company has taken steps to notify other manufacturers of catheters of the potentially related issues involving nylon and tungsten in case the problem is not specific to their products.
Reporting Adverse Events
The FDA understands that healthcare professionals that use these types of catheters and patients that have undergone procedures involving the defective Cook Medical angiographic catheter are likely to be affected by the recall.
Patients injured by the angiographic catheter or family members who have lost a loved one due to a procedure using an effective catheter can report the adverse event or side effect to the FDA under their MedWatch Adverse Reporting program. Complaints can be filed with the FDA online or by sending a fax or using regular mail.
Victims and surviving family members can also report their adverse event to the customer relations department at Cook Medical within the same timeframe by calling (800) 457-4500 or by email.
Each recall product can be identified by the product label and part number. Consumers could come across the products anywhere because they were globally distributed. The Beacon Tip angiographic tip was designed for experienced physicians who received sufficient training to ensure the device was used according to its design. Cook Medical recommends that doctors, patients, and consumers affected by the recall defective product should not only contact the company and the FDA but also:
- Review every affected product by its lot number to determine if the specific product still on hand has been recalled.
- Ensure all unused recalled products that are still in inventory are immediately quarantined to avoid further unwitting interaction with patients.
- Gather all unused Cook Medical products and return them immediately to the manufacturer to avoid the potential harm of more patients.
Beacon Catheter Lawsuits
By early 2015, the FDA (Food and Drug Administration) had received and released reports on at least 150 adverse events that involved Cook Medical Beacon Tip Catheters, where the product broke, fractured or split inside the patient’s arteries. The mounting complaints led to a Class I voluntary recall by the company to pull the product from the medical marketplace.
Since before and after the recall was first initiated, many patients have needed to undergo a complicated surgery to remove the splintered pieces that had relocated to other areas in the body including deep in femoral arteries. As a result, many patients have required additional cardiac monitoring and care. This is because the separation, splitting or fracturing of the tip has the potential of blocking the flow of blood to one or more organs. Bloomington Indiana-based Cook Medical claims that they have notified the FDA and other federal government regulatory agencies of the seriousness of these problems.
A worldwide recall has been issued by the Beacon Tip Angiographic Catheter manufacturer Cook Medical after it received many complaints concerning the products defective design. Before the device was pulled from the medical marketplace, it split, broke or fractured into pieces while inside many patients’ body who were undergoing procedures requiring the device.
Let Us Fight Aggressively on Your Behalf
The medical device litigation team at the Drug Law Center are now focusing on providing legal representation, advice, and counsel to plaintiffs involved in Cook Medical angiographic tip catheter recall lawsuits.
Complementary Confidential Case Evaluation
If you experience an injury or a loved one died prematurely due to the tip of the catheter fracturing, separating, splitting, or breaking, you need to contact the reputable team of attorneys at the Drug Law Center immediately. Our lawyers are ready to fight aggressively on your behalf to ensure you receive adequate financial recompense for your damages.
Let our attorneys review your case in a no obligation lawsuit evaluation at no charge to you. Our law firm has vast resources to investigate your case, gather evidence and obtain legal and medical experts to prove your claim at trial. We offer a “no win/no fee” guarantee to ensure your family pays nothing if we are unable to settle your case out of court or win your case at trial.