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

Device Problem Defective Device (2588)

Patient Problems Granuloma (1876); Fibrosis (3167)

Event Date 10/01/2022

Event Type  malfunction  

Manufacturer Narrative

Block b3: approximated based on the date the article was published.Block d4, h4: the device upn and lot number are unknown; therefore, the lot expiration and device manufacture dates are unknown.Block g2: literature source satoi s, et.Al.(2022).Foreign body reaction following use of submucosal lifting agent for endoscopic resections.The american journal of gastroenterology.117 (10s): e2154-e2154.Doi: 10.14309/01.Ajg.0000870280.04417.E5 block h6: impact codes f1001 capture the reportable event of aborted procedure.

Event Description

Boston scientific became aware of an event involving orise gel through the article, foreign body reaction following use of submucosal lifting agent for endoscopic resections, by sera satoi, et al.Per the article, the patient underwent endoscopic mucosal resection (emr) procedure in the duodenum.Tissue was lifted by submucosal injection of 4 ml orise gel; however, the procedure was aborted because the center of the polyp was fixed and could not be lifted.65 days later, the patient underwent repeat esophagogastroduodenoscopy (edg) to remove the lesion.Orise gel was attempted; however, the lesion could not be lifted due to severe fibrosis thus hybrid emr was used to excise the lesion.Pathologic examination revealed fragments of adenoma.In addition, submucosa showed foreign material with associated foreign giant cell reaction, consistent with the site prior to the procedure.

• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17932951
• MDR Text Key: 325712054
• Report Number: 3005099803-2023-05458
• 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: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/13/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male