ORISE GEL

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING AGENT DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, 6 ML OF ORISE GEL WAS USED AS A LIFTING AGENT FOR A 3.5 CM RECTAL LESION. RESECTION WAS NOT ATTEMPTED, AND BIOPSIES WERE TAKEN, WHICH SHOWED TUBULAR ADENOMA. TWO MONTHS LATER, ENDOSCOPIC SUBMUCOSAL DISSECTION WAS PERFORMED USING HYDROXYETHYL STARCH BASED ON THE ENDOSCOPISTS PREFERENCE. THERE WAS A FOCAL AREA OF NON-LIFTING SEVERE SUBMUCOSAL FIBROSIS WITH POSSIBLE NODULE THAT WAS CHALLENGING TO DISSECT. A CLIP WITH ELASTIC TRACTION DEVICE WAS USED TO IMPROVE VISUALIZATION AND COMPLETE THE DISSECTION. PATHOLOGY REVEALED ADENOMA AND THE AREA OF FIBROSIS SHOWED SUBMUCOSAL LIFTING AGENT GRANULOMA WITH GIANT CELLS AND CHRONIC INFLAMMATION.

Additional Manufacturer Narrative

DATE OF EVENT: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. INITIAL REPORTER FACILITY NAME: (B)(6). (B)(4).