Lawsuits and complaints filed against Cook Medical over IVC filter failures have plagued the company for several years. However, IVC filters aren’t the only devices that the medical device manufacturer produces. Nor are they the only devices that are likely causing serious legal problems for the company.
An angiographic catheter is a device that is used to thread its way into a patient’s heart for the purpose of injecting various dyes and contrast agents in preparation for a cardiac angiogram. Patients undergo cardiac angiograms when doctors have reason to believe that there may be damage to blood vessels in a patient’s heart. Bulges, blockages, or a number of other causes for such damage can exist and the angiogram makes this damage easier to see during an X-ray or other digital imaging process.
In July of 2015, Cook Medical issued a recall for various lots of its Beacon Tip angiographic catheters. That recall has since expanded and the FDA has designated the recall as a Class I; its most critical type of recall action.
The reason for the Cook angiographic catheter recall is especially horrifying given the device’s stated purpose of working within a patient’s heart and blood vessels. Reports indicated that the tip of the catheter could possibly split or separate while in a patient’s bloodstream. Such a split or separation of the catheter while in the patient’s bloodstream can have very serious consequences; including the death of the patient. Surgery could also become necessary to remove the foreign object.
At the very least, such a failure could lead to the device no longer being able to function and the need to conduct another procedure on the patient with a non-malfunctioning catheter.
Over 400,000 Cook Medical angiographic catheters are affected by this latest recall action.
It is worth noting that device breakage within the patient’s bloodstream is also a primary concern in the IVC filter lawsuits currently filed against Cook Medical. In those cases, parts of the IVC filter placed in the patient’s inferior vena cava have broken off and traveled throughout the patient’s bloodstream, or become even become lodged in place somewhere else. Such a failure can cause a multitude of complications ranging from device migration and an inability to retrieve it, to stroke and the death of the patient.
Why Cook’s devices are seemingly incapable of staying in one piece once placed within a patient will be for juries to discover. In the meantime, one can only hope that their manufacturing issues are resolved quickly before another unsuspecting patient is irreparably harmed by a Cook Medical device.