Dive Brief:
- The Food and Drug Administration has categorized Abbott Laboratories’ recall of 4,800 Dragonfly OpStar Imaging Catheters as a Class I event, reflecting the potential for a problem with the device that could lead to vascular injuries.
- Abbott issued an urgent notice about the catheters last month to warn customers of the risk of proximal markers separating from the devices. At the time, the company had received five complaints including one case of an embolism that required further intervention. According to the FDA's Thursday notice, no deaths have been associated with the use of the device due to the recall issue.
- The FDA and Abbott are asking customers with affected devices to stop using them immediately and return all stock to the company. No action is required when affected devices have already been used successfully. A Class I label is the agency's most serious recall classification.
Dive Insight:
Abbott received 510(k) clearance for the affected device in 2019, positioning it to sell a product intended for the imaging of coronary arteries in patients who are candidates for interventional procedures via the lumen. The device was built on more than 20 years of work at LightLab Imaging, St. Jude Medical and Abbott, which came to own the technology as the result of a series of deals culminating in a $25 billion buyout.
The latest version of the optical coherence tomography intravascular imaging technology is designed to make it easier to access distal lesions and provide brighter and higher quality images. One of the new features relates to the position of the marker band furthest from the tip of that catheter. By locating the proximal marker further from the imaging lens, Abbott enabled 75mm of image acquisition, 50% more than was possible than when using the C7 Dragonfly Imaging Catheter.
However, Abbott has now encountered a problem with the proximal marker in certain lots. In some cases, the marker can become loose and separate from the device while in use.
After separating, the marker may remain in the patient after the catheter is removed, potentially leading to vascular injuries such as blockages, clots, tears, inadequate blood supply to the heart and heart attack as well as infection and death.
Abbott has received five complaints about loose proximal markers. On two occasions, the marker separated from the device. One patient suffered an embolism that required additional intervention to resolve. The patient suffered no immediate adverse consequences. The FDA’s adverse event database contains reports of events that match Abbott’s descriptions of the fault.
Abbott’s investigation has determined that the problem is limited to the lots covered by the recall and plans to “implement appropriate corrective actions to ensure product performance,” the company said in its urgent field safety notice.
The recall is the first related to the device.
