FDA MedWatch - Dragonfly OpStar Imaging Catheter by Abbott Medical:

Class I Recall - Due to Potential Loose Catheter Marker Band That May Cause Patient Harm

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Dragonfly OpStar Imaging Catheter by Abbott Medical: Class I Recall - Due to Potential Loose Catheter Marker Band That May Cause Patient Harm AUDIENCE: Patient, Health Professional, Risk Manager, Cardiology ISSUE: Abbott is recalling certain lots of the Dragonfly OpStar imaging catheter because the marker band farthest from the catheter tip (proximal marker) may become loose and, in two instances, has been observed to separate from the catheter while being used on a person. A loose marker band that has separated from the device may remain in the body after the catheter is removed, potentially leading to vascular injuries, including but not limited to embolism (blockage of the vessel), thrombosis (blood clot), dissection (tear), ischemia (inadequate blood supply to the heart), infarction (heart attack), infection, or death. There have been 5 incidents and 1 injury related to this device issue. No deaths have been associated with the use of this device due to this issue. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The Dragonfly OpStar imaging catheter with optical coherence tomography (OCT) imaging system is designed to provide imaging of blood vessels that carry blood and oxygen to the heart (coronary arteries) in people who are candidates for catheter-based, minimally invasive, interventional procedures to address coronary artery disease. RECOMMENDATIONS: On April 11, 2022, Abbott issued an Urgent Medical Device Recall letter to all customers who received affected devices. The following instructions were included: Immediately stop using devices from affected lots. Review inventory and complete the Effectiveness Check Form Included with the Urgent Medical Device recall letter. Return all unused affected devices to the company. Share this information with all relevant personnel. Notify anyone who may have received these affected products through additional distribution or transfer. Report any product performance issues or adverse events to the company. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Follow us on Twitter at @FDAMedWatch

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