ORISE GEL

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING AGENT IN THE ASCENDING COLON DURING A RESECTION ON AN UNKNOWN DATE. A 60-YEAR-OLD FEMALE PATIENT UNDERWENT A SCREENING COLONOSCOPY TO REVEAL A 2 CM ELEVATED LATERALLY SPREADING POLYP. THE POLYP WAS INJECTED WITH ORISE GEL AND A PIECEMEAL RESECTION WAS PERFORMED. FOUR MONTHS LATER DURING A FOLLOW-UP COLONOSCOPY, THE FORMER POLYPECTOMY SITE APPEARED RAISED AND SUSPICIOUS FOR A SUB-EPITHELIAL LESION. REPORTEDLY, IT WAS AGAIN RESECTED, AND THE HISTOPATHOLOGY REPORT REPORTED IT TO BE COLONIC MUCOSA WITH SUB-EPITHELIAL AMORPHOUS FOREIGN MATERIAL (ORISE TM), NEGATIVE FOR MUCIN AND AMYLOID STAINS. THE AMORPHOUS FOREIGN MATERIAL DUE TO ORISE GEL RESULTED IN AN ADDITIONAL BIOPSY/INTERVENTION.

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. REPORT SOURCE: LITERATURE. THE CORRESPONDING AUTHOR IS NEHA SHARMA. THE AMERICAN JOURNAL OF GASTROENTEROLOGY DOI: 10.14309/01.AJG.0000780460.53416.B7. (B)(4).