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)

Event Date 10/01/2022

Event Type  Injury  

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.Impact code (b)(4).

Event Description

It was reported to boston scientific corporation that orise gel was used as a lifting agent in the colon during a colectomy procedure performed on an unknown date.Orise gel was used to lift an 8mm polyp in the colon.The polyp was resected using a hot snare and sent to pathology, which showed invasive carcinoma.A second gastroenterology pathologist reviewed the polyp and confirmed invasive cancer.In a photo provided by the customer, remnant orise gel was observed at the resection site.Subsequently, the patient underwent a computed tomography (ct) scan 11 days after the colon polyp removal.The ct scan showed area wall thickening measuring 1cm in thickness and 3cm in length concerning for cancer.The patient was referred to another gastroenterologist for a repeat endoscopy procedure, and also to a surgeon.However, the patient never saw the second gastroenterologist and was taken for colonic resection by the surgeon.The resected specimen showed a 1.2cm x 1cm firm tan lesion.Pathology results noted no evidence of cancer in the specimen or granuloma/foreign body reaction.

Event Description

It was reported to boston scientific corporation that orise gel was used as a lifting agent in the colon during a colectomy procedure performed on an unknown date.Orise gel was used to lift an 8mm polyp in the colon.The polyp was resected using a hot snare and sent to pathology, which showed invasive carcinoma.A second gastroenterology pathologist reviewed the polyp and confirmed invasive cancer.In a photo provided by the customer, remnant orise gel was observed at the resection site.Subsequently, the patient underwent a computed tomography (ct) scan 11 days after the colon polyp removal.The ct scan showed area wall thickening measuring 1cm in thickness and 3cm in length concerning for cancer.The patient was referred to another gastroenterologist for a repeat endoscopy procedure, and also to a surgeon.However, the patient never saw the second gastroenterologist and was taken for colonic resection by the surgeon.The resected specimen showed a 1.2cm x 1cm firm tan lesion.Pathology results noted no evidence of cancer in the specimen or granuloma/foreign body reaction.Dr.(b)(6) had undergone surgery based on ct findings.We did not have the pathology finding from the surgical specimen.Dr.Wuerth has reached out to me and confirmed that the surgical specimen did show foreign body reaction/ granuloma, and no malignancy was identified.

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 lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h2: block b5 has been updated based on the additional information received on november 14, 2022.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; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15738614
• MDR Text Key: 303143437
• Report Number: 3005099803-2022-06353
• 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,Followup
• Report Date: 12/08/2022

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: 10/10/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/14/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 92926415-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention