ORISE GEL

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED TO LIFT A POLYP IN THE CECUM DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) IN (B)(6) 2022. DURING THE PROCEDURE, APPROXIMATELY 4-6 ML OF ORISE GEL WAS INJECTED INTO THE PATIENT'S CECUM TO RESECT A POLYP. IT WAS NOTED THE PATIENT'S STOMACH WAS INSUFFLATING AND THE PHYSICIAN OBSERVED A PERFORATION IN THE PATIENT'S HEPATIC FLEXURE, AWAY FROM THE LESION SITE. THE PERFORATION WAS TREATED WITH A CLIP, HOWEVER, THE PHYSICIAN FELT UNCOMFORTABLE FINISHING THE ESD DUE TO THE PERFORATION AND THE PROCEDURE WAS RESCHEDULED. THE PATIENT RETURNED SOMETIME IN 2023 TO COMPLETE THE ESD PROCEDURE. THE PHYSICIAN REMARKED THAT THE ORISE GEL HE HAD INJECTED PREVIOUSLY IN (B)(6) 2022 AND LEFT UNRESECTED DID MAKE IT CHALLENGING FOR HIM TO COMPLETE THE ESD DURING THE FOLLOW-UP PROCEDURE, AND SOME DEFORMATION CAUSED BY ORISE UNDER THE LESION WAS OBSERVED. IT IS UNKNOWN WHAT CAUSED THE PERFORATION; HOWEVER, IT WAS NOTED BY THE PHYSICIAN THAT IT WAS PROCEDURAL RELATED AND NOT DEVICE RELATED.

Additional Manufacturer Narrative

BLOCK B3: 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. BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H6: PATIENT CODE (B)(6): PERFORATION IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF A PROCEDURE-RELATED PERFORATION.