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 Abdominal Pain (1685); Fever (1858); Granuloma (1876)

Event Date 02/01/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that orise gel was used as a lifting agent during a colonoscopy procedure performed on an unknown date.During an initial colonoscopy at an outside facility, a 5cm lesion was observed in the right colon at hepatic flexure.Submucosal lifting was attempted with orise gel; however, the lesion was deemed non-lifting and the patient was referred out to another physician.Sometime after the initial colonoscopy, the patient experienced fever and right abdominal pain.A few weeks after the initial procedure, the patient underwent a repeat colonoscopy.The 5cm lesion was observed, which was deemed questionable for malignancy on examination.No polypectomy or intervention was noted at this time.The patient was sent for a computed tomography (ct) scan to further analyze the colonic lesion.Results not only showed the colonic lesion, but also a lesion in the right inferior lobe of the liver.At this time, the patient underwent a right hemicolectomy procedure and removal of the liver lesion.Pathology of the colon showed only adenomatous tissue, but the liver lesion showed significant foreign body reaction.The physician believes the liver foreign body reaction was a result of direct deep injection of orise gel into the liver.Additionally, they noted if orise gel had not been used during the initial colonoscopy, surgery could have been avoided.There are no further patient complications reported at this time.

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.Imdrf 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: 16425397
• MDR Text Key: 310045760
• Report Number: 3005099803-2023-00854
• Device Sequence Number: 1
• Product Code: PLL
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/23/2023

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: 02/03/2023
• Initial Date FDA Received: 02/23/2023
• 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