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 11/01/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that orise gel was used as a lifting agent on an unknown date.After the completion of endoscopic mucosal resection (emr) and/or endoscopic submucosal dissection (esd) procedures, the physician is concerned for fibrosis in submucosa.Reportedly, they have observed submucosal distortions or mass formations following the use of orise gel.These distortions/ mass formations have been assessed by performing biopsies on the lesion and repeat mucosal resection.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

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.(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: 15895509
• MDR Text Key: 304622742
• Report Number: 3005099803-2022-07131
• 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: 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: 11/05/2022
• 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