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); Fibrosis (3167)

Event Date 04/01/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that orise gel was used to lift a polyp during a resection procedure on an unknown date.The physician was unable to resect the lesion during the initial procedure and referred the patient for an endoscopic submucosal dissection (esd) procedure.About 3-4 months later, during the esd procedure, the polyp appeared firm and adherent to the muscle layer.As the physician had prior imaging from the index procedure, the polyp gave the impression of a more advanced tumor.The submucosal dissection was difficult to perform as there was little identifiable submucosa, but rather thick white slab of fibrosis-like material.The physician had to dissect around this area, taking more tissue than intended.The pathology showed foreign body reaction to orise gel.There are no further patient complications reported at this time.

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 upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: impact code f23 captures the reportable event of unexpected medical 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 LIMITED; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16911979
• MDR Text Key: 315011258
• Report Number: 3005099803-2023-02393
• 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: Recall
• Type of Report: Initial
• Report Date: 05/11/2023

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: 04/17/2023
• Initial Date FDA Received: 05/11/2023
• 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