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

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Granuloma (1876); Obstruction/Occlusion (2422)

Event Date 07/16/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that orise gel was used during a colonoscopy performed on (b)(6), 2021.The patient had a polyp removed using orise gel as the lifting agent.During a follow-up surveillance colonoscopy, they found the patient had developed a stricture at the site of the resection.Due to the stricture, a partial colectomy was performed.Surgical pathology demonstrated that there was a giant cell reaction to the orise gel at the site, and they believe it was this granulomatous reaction that likely caused the stricture.The patient tolerated the procedure without complication and was admitted post-operatively for monitoring.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.

Event Description

It was reported to boston scientific corporation that orise gel was used during a colonoscopy performed on (b)(6) 2021.The patient had a polyp removed using orise gel as the lifting agent.During a follow-up surveillance colonoscopy, they found the patient had developed a stricture at the site of the resection.Due to the stricture, a partial colectomy was performed.Surgical pathology demonstrated that there was a giant cell reaction to the orise gel at the site, and they believe it was this granulomatous reaction that likely caused the stricture.The patient tolerated the procedure without complication and was admitted post-operatively for monitoring.

Manufacturer Narrative

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 h2: correction: block h6 device code has been updated.Block h6: impact code f19 captures the reportable event of surgical intervention.

• 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; business & technonlogy park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15407094
• MDR Text Key: 299755611
• Report Number: 3005099803-2022-04988
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

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: 08/15/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention