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

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

Patient Problem Granuloma (1876)

Event Date 05/01/2023

Event Type  Injury  

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 lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g3: literature source journal article: rex dk, lahr re.The demise of orise, a submucosal lifting agent for endoscopic resection.Ame case rep 2023;7:11.Doi: 10.21037/acr-23-15 block h6: impact code f19 captures the reportable event of surgical intervention.

Event Description

Boston scientific corporation became aware of an event related to orise gel from an editorial ''the demise of orise, a submucosal lifting agent for endoscopic resection'' written by douglas rex., md and rachel lahr.The article mentions a monthly live web-based course on endoscopic mucosal resection (emr) procedures broadcasted from the author's center, where an unknown physician describes a related story from their home institution.The case involved submucosal distortion observed in a rectal emr scar following the use of orise injection.This distortion raised concerns about potential submucosal tumor growth, leading to surgical resection.However, the resected specimen did not show any cancerous growth, but rather exhibited an accumulation of eosinophilic material and multi-nucleated giant cells, indicative of an orise reaction.These changes, known as ''lifting granuloma,'' highlight the significance of submucosal distortion in emr scars, as it can have important adverse clinical outcomes.

• 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: 17167645
• MDR Text Key: 317631370
• Report Number: 3005099803-2023-03352
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/20/2023

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: 05/25/2023
• Initial Date FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: 92970101-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention