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); Inflammation (1932); Tissue Breakdown (2681); Fibrosis (3167)

Event Date 08/01/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that orise gel was used as a lifting agent during an endoscopic submucosal dissection (esd) procedure on an unknown date.During the procedure, 6 ml of orise gel was used as a lifting agent for a 3.5 cm rectal lesion.Resection was not attempted, and biopsies were taken, which showed tubular adenoma.Two months later, endoscopic submucosal dissection was performed using hydroxyethyl starch based on the endoscopists preference.There was a focal area of non-lifting severe submucosal fibrosis with possible nodule that was challenging to dissect.A clip with elastic traction device was used to improve visualization and complete the dissection.Pathology revealed adenoma and the area of fibrosis showed submucosal lifting agent granuloma with giant cells and chronic inflammation.

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.Initial reporter facility name: (b)(6).(b)(4).

• 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 CORPORATION; model farm road; cork
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15894299
• MDR Text Key: 304607578
• Report Number: 3005099803-2022-07124
• 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: Notification
• Type of Report: Initial
• Report Date: 12/01/2022

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: 11/29/2022
• Initial Date FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: 92926415-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female