MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORISE GEL; SUBMUCOSAL INJECTION AGENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Granuloma (1876); Perforation (2001)

Event Date 05/01/2023

Event Type  Injury  

Event Description

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.

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.

• Brand Name: ORISE GEL
• Type of Device: SUBMUCOSAL INJECTION AGENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC LIMITED; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17075749
• MDR Text Key: 316747914
• Report Number: 3005099803-2023-02868
• Device Sequence Number: 1
• Product Code: PLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 92970101-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention