ORISE GEL

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING AGENT ON AN UNKNOWN DATE. AFTER THE COMPLETION OF ENDOSCOPIC MUCOSAL RESECTION (EMR) AND/OR ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURES, THE PHYSICIAN IS CONCERNED FOR FIBROSIS IN SUBMUCOSA. REPORTEDLY, THEY HAVE OBSERVED SUBMUCOSAL DISTORTIONS OR MASS FORMATIONS FOLLOWING THE USE OF ORISE GEL. THESE DISTORTIONS/ MASS FORMATIONS HAVE BEEN ASSESSED BY PERFORMING BIOPSIES ON THE LESION AND REPEAT MUCOSAL RESECTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

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. (B)(4).