Cook Begins Relaunch of Beacon Tip Catheter Line
April 2, 2018—Cook Medical has begun reintroducing its line of Beacon Tip angiographic catheters, starting in the United States and Canada with the 5-F Beacon Tip Torcon NB Advantage line.
Certain lots of the workhorse radiopaque-tipped catheter line were voluntarily recalled starting in 2015, and in 2016, Cook announced that the entire product line was being pulled due to tip splitting and/or fracture.
Cook now believes it has remedied the issue of degradation of the nylon-coated tungsten tip and is ready to begin a staged relaunch of the popular catheters.
Researching the incidences of tip degradation for a device that had been on the market and in wide global use since the 1990s, Cook determined the root cause to be related to material interactions with environmental factors such as heat, humidity, and the vaporized hydrogen peroxide (VHP) used in whole-room sterilization practices. When the company analyzed the reports of tip degradation, they found that the issues seemed to be occurring in clusters, rather than across all types of hospitals and locations. They then looked for common patterns at the centers reporting issues and zeroed in on environmental factors such as those used in whole-room sterilization, which was a relatively new practice, as well as storage in high heat and humidity areas.
Aimed at preventing hospital-acquired infections, whole-room sterilization can involve the use of high-intensity ultraviolet lighting, high-temperature–producing devices, or VHP. In comments to Endovascular Today at the time of the recall, Cook Medical President Pete Yonkman said that the company was evaluating whether the issue might be related to the devices being left in the room at the time of sterilization.
Speaking with Endovascular Today ahead of the relaunch, Mark Breedlove, Vice President of Cook's Vascular division, says the Beacon Tip catheters will now be shipped in foil packaging to prevent exposure to VHP. The packaging will also contain a desiccant pouch to combat potential effects of environmental humidity.
Mr. Breedlove noted that while Beacon Tip production was offline, the company used the time to examine every aspect of its manufacturing process. Although the process has been refined, he says the product will continue to be made with the same materials and configurations and return to market with the same characteristics that physicians were used to, such as its torqueability, feel, and visibility.
The 5-F line comprises the vast majority of catheters used, so the decision was made to relaunch this line first, followed by others such as the 4-F and hydrophilic lines. Cook aims for a release in Europe in the second half of 2018, with other markets to follow.
Reflecting on what was learned during the 2 years Beacon Tip was off the market, Mr. Breedlove described some of the feedback its employees had received from physicians who no longer had access to the workhorse device, and how the response from its customers was a strong reminder of the importance of the Beacon Tip product line.
"People don't usually talk about catheters, access technology, and diagnostic technology as much [as primary therapy devices], and you don't realize how important it is to the procedure until it's gone," said Mr. Breedlove. Much of the activity during the recall focused not only on bringing the catheters back to market, but keeping them on the market by appreciating the need to continually evolve workhorse lines to ensure they meet the demands of evolving health care environments.
For example, although no other product lines were shown to have been adversely affected by the environmental factors that led to Beacon Tip's recall, Cook has begun testing other products by exposing them to VHP.
Headquartered in Bloomington, Indiana, Cook Medical has also added manufacturing facilities in Canton, Illinois, the boyhood home of company founder Bill Cook. Production of the Beacon Tip family of catheters largely took place in a Canton facility and comprised the majority of its workload. However, immediately after the 2016 recall was announced, Mr. Yonkman flew to the facility to address the employees and assure them their jobs were safe. While Beacon Tip production was offline, Cook moved production of other technologies to the Canton location, increasing overall capacity and inventory on those lines. Mr. Breedlove noted that the company now plans to add more jobs to accommodate the continued manufacture of those products as well as resume Beacon Tip's production in Canton.