ASCENDO

Description of Event or Problem

THE USER FACILITY REPORTED THAT A PATIENT RECEIVED A "BURN" ON THEIR ASCENDING COLON AFTER BEING INJECTED WITH ASCENDO SUBMUCOSAL LIFTING AGENT. IT IS UNKNOWN IF ADDITIONAL MEDICAL TREATMENT WAS ADMINISTERED.

Additional Manufacturer Narrative

THE DEVICE SUBJECT OF THE REPORTED EVENT WAS RETURNED FOR EVALUATION AND NO ABNORMALITIES WERE NOTED. A ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER, WAS MOST LIKELY THE RESULT OF AN ALLERGIC REACTION WITH THE PATIENT. THE IFU FOR THE ASCENDO SUBMUCOSAL LIFTING AGENT STATES, "DURING THE PROCEDURE DO NOT EXCEED A TOTAL DOSE OF 50ML PER PATIENT, EITHER IN SINGLE OR IN MULTIPLE ADMINISTRATIONS. DO NOT USE THIS MEDICAL DEVICE WITH DISINFECTANTS CONTAINING QUATERNARY AMMONIUM SALTS (E.G. BENZALKONIUM CHLORIDE). THIS MAY CAUSE PRECIPITATE. DO NOT REUSE THE ASCENDO SUBMUCOSAL LIFTING AGENT. IT CAN CAUSE SIDE EFFECTS LIKE INFLAMMATION, INFECTION, ETC. THE ASCENDO SUBMUCOSAL LIFTING AGENT IS INTENDED FOR USE IN THE GASTROINTESTINAL ENDOSCOPIC PROCEDURES FOR SUBMUCOSAL LIFT OF POLYPS, ADENOMAS, EARLY-STAGE CANCERS, OR OTHER GASTROINTESTINAL MUCOSAL LESIONS PRIOR TO EXCISION WITH A SNARE OR ENDOSCOPIC DEVICE." A 3-YEAR COMPLAINT REVIEW WAS CONDUCTED AND CONFIRMED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.