ORISE GEL
Received Oct 28, 2022 · Event occurred Oct 13, 2022
Report 3005099803-2022-06240 · MDR key 15691774
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING AGENT IN THE DUODENUM DURING A GASTROSCOPY WITH ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2022. TWO DAYS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED POST EMR DUODENAL BLEEDING AND PRESENTATION OF MELENA. THE PATIENT UNDERWENT REPEAT GASTROSCOPY WITH HEMOSPRAY TO TREAT THE BLEEDING. THE EXACT CAUSE OF THE BLEEDING/HEMORRHAGE IS UNKNOWN. THE PHYSICIAN DEEMED THE EVENT HAD A RELATIONSHIP TO THE PROCEDURE AND WAS NOT DIRECTLY RELATED TO THE GEL.
Additional Manufacturer Narrative
BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK H2: BLOCK B5 AND BLOCK E1 WERE UPDATED WITH ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 BLOCK H6: IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF UNEXPECTED MEDICAL INTERVENTION. BLOCK H11: CORRECTION: BLOCK E1 INITIAL REPORTER ADDRESS HAS BEEN CORRECTED BASED ON THE INFORMATION AVAILABLE IN THE COMPLAINT RECORD. ADDITIONAL INFORMATION: BLOCK B5 HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION THAT A CAPTIVATOR SNARE WAS USED FOR RESECTION IN THE INITIAL EMR.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING AGENT IN THE DUODENUM DURING A GASTROSCOPY WITH ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2022. TWO DAYS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED POST EMR DUODENAL BLEEDING AND PRESENTATION OF MELENA. THE PATIENT UNDERWENT REPEAT GASTROSCOPY WITH HEMOSPRAY TO TREAT THE BLEEDING. THE EXACT CAUSE OF THE BLEEDING/HEMORRHAGE IS UNKNOWN. THE PHYSICIAN DEEMED THE EVENT HAD A RELATIONSHIP TO THE PROCEDURE AND WAS NOT DIRECTLY RELATED TO THE GEL. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022. IT WAS CONFIRMED THAT A CAPTIVATOR SNARE WAS USED FOR RESECTION IN THE INITIAL EMR.