SharkCore™ FNB Exchange System

Risk Information: Those associated with gastrointestinal endoscopy include, but are not limited to: Perforation, hemorrhage, aspiration, fever, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest, infection, allergic reaction to medication, damage to blood vessels, nerve damage, and acute pancreatitis. Those associated with EUS needle biopsy include but are not limited to: bleeding, pain, death, peritonitis, infection / bacteremia, tumor seeding of the needle tract, and needle fracture requiring intervention for removal. Please refer to the product user manual or www.medtronic.com/gi for detailed information.