Defective Catheters Causing Injury

Santa Clara, CA: The number of catheters reported to be defective over the last few years is mind-boggling. Over the past year alone several medical device manufacturers have recalled a combined four million catheters. Why so many? A study published yesterday may give one explanation. READ MORE

Washington, DC: When the Fetch 2 Aspiration Catheter was originally launched by Bayer Medical Care Inc., (Bayer), there was no shortage of platitudes which, sometime later presented as a stark contrast to the eventual global recall that resulted in many a lawsuit amidst allegations of defective catheters causing injury.


“Why Use Fetch 2 Aspiration [Catheter]?” was a question posed by the online brochure posted by Bayer when the device was released. “You choose a manual aspiration device for its ease of use and its ability to quickly resolve small, fresh thrombus, in coronary arteries. The Fetch 2 Aspiration Catheter offers enhanced handling and kink resistance thanks to a variable pitch coiled proximal shaft. You want to reach into small vessels and cross tight lesions. The Fetch 2 Aspiration Catheter can get you there with a low 4.2 French catheter profile and convex-cut opening to reduce risk of vessel wall damage.


“Finally, you want your aspiration device to effectively restore flow. The Fetch 2 Catheter has demonstrated effective clot removing ability, despite its low profile.”


Those lofty platitudes soon evaporated, however when the Fetch 2 Aspiration Catheter was recalled in March of last year over complaints related to breakage associated with the device shaft.


The recall, initiated by medical device manufacturer Boston Scientific Corporation (Boston Scientific) after acquiring the Fetch 2 catheter product line from Bayer, was a voluntary recall nonetheless supported by the US Food and Drug Administration (FDA). The recall was broad in scope, characterized as a global recall of product manufactured between June 11, 2014 and February 19, 2016. At the point at which the recall was announced there were 21,155 devices on the market that were considered subject to the Fetch 2 Aspiration Catheter recall.


“Boston Scientific Corporation is recalling the Fetch 2 Aspiration Catheter because the catheter shaft may break at various points along the device, before or during procedures,” the recall notice stated. “If breakage occurs while the device is in a patient, pieces of the catheter may block blood supply to the heart or blood vessels. This could result in the need for additional medical procedures, patient injury, or death.”


A Class 1 recall, under which the Fetch 2 fell, is considered the most serious recall available to be issued by the FDA. “Use of these devices may cause serious injury or death,” the regulator said in its recall notice.


The catheters were recalled simultaneously in the US and in Canada on March 22 of last year. Less than a month later Boston Scientific issued a press release dated April 8, 2016 formally announcing the recall.


The recall was officially terminated about 16 months later, August 11 of this year. The official posting on the FDA website indicates the Fetch 2 Aspiration Catheter was among the scores of problematic medical devices initially approved through an FDA 510(k) Clearance [#K101354]. Approved under a substantially equivalent (SESE) designation, the decision reflects no third party review.
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Santa Cruz, CA: Another catheter was recalled last week, and this one got a Class 1 recall category, meaning the most serious kind.


The FDA recalled a bridge occlusion balloon catheter “due to the possibility of blocked guidewire lumen in select device units”. The Bridge Occlusion Balloon Catheter, made by Spectranetics, is designed to temporarily block the superior vena cava in the event of hemorrhage, according to the alert. The company sent a notice directing physicians to confirm that the guidewire lumen is open and unblocked prior to start of the procedure and to have backup units on hand, and the FDA stated that Spectranetics recommends health care professionals and patients report any adverse events or side effects related to the use of the product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.


But what are the chances of a patient reporting an adverse event, given that the balloon catheter has been slapped with a Class 1 recall? The FDA defines this category as  “ a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” Over 1,900 devices manufactured between Feb. 13 and July 18, 2017, and distributed between Feb. 24 and July 31, 2017, were recalled in the U.S., according to the agency. The amount of catheter recalls over the past few years is staggering: topping the biggest medical device recall in 2016 (according to medtechchina was Cook Medical's Single Lumen Central Venous Catheter Sets and Trays; Single Lumen Pressure Monitoring Sets and Trays; Femoral Artery Pressure Monitoring Catheter Sets and Trays; Radial Artery Pressure Monitoring Catheter Sets and Trays. And last October Vascular Solutions recalled more than 15,000 catheters.


Why are so many catheters recalled?


To start with, catheters are flexible tubes inserted through narrow openings into body cavity. The recalled catheters are not urinary catheters; those recalled are used for medical procedures, such as injecting dye for angiograms, or removing small blood clots from veins and arteries. According to the Journal of Medical Engineering & Technology the problem with the affected catheters is that they are prone to degrade and fracture. Tips and other components have broken or separated, resulting in serious patient injuries, and even in patient death. Once these fractures have broken loose, they can potentially float freely in the bloodstream and travel to the heart, lungs, or other vital organs. Hence a Class I recall.


But liability has yet to be definitively determined: At what point during manufacture have the catheter defects occurred? One law firm, Chandler Mathis Zivley, says that, “Investigators are now looking into the possibility that corners have been cut in attempts to streamline costs, resulting in products that are less sturdy and more prone to fail during use. One aspect of the investigation is focused on whether having products manufactured offshore, in an attempt to improve efficiency and lower costs, has resulted in inadequate testing and insufficient supervision that may underlie the problems.” Stay tuned…
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