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

Model Number	M00519221
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Date of event: the exact date of the event is unknown.It was reported that the esd procedure was performed in april 2022.The provided event date was chosen as a best estimate.
Event or Problem Description
It was reported to boston scientific corporation that orise gel was used in the duodenum during an endoscopic submucosal dissection (esd) procedure performed in (b)(6) 2021.In (b)(6) 2022, a positron emission tomography (pet) scan was performed to evaluate a lung nodule for a separate issue.The pet scan showed a "hot spot" in the duodenum at the same location as the esd performed in (b)(6) 2021.It was stated that the physician attributed this finding to orise inflammation.As a result of the findings on the pet scan, the patient underwent an esophagogastroduodenoscopy (egd) procedure with biopsy in (b)(6) 2022.The biopsy showed "peptic duodenitis with ulceration".
Additional 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 b3: the exact date of the event is unknown.It was reported that the esd procedure was performed in (b)(6) 2022.The provided event date was chosen as a best estimate.Block h11: blocks d4, h6 (evaluation method codes, evaluation method codes and evaluation conclusion codes) have been corrected.
Event or Problem Description
It was reported to boston scientific corporation that orise gel was used in the duodenum during an endoscopic submucosal dissection (esd) procedure performed in (b)(6) 2021.In february 2022, a positron emission tomography (pet) scan was performed to evaluate a lung nodule for a separate issue.The pet scan showed a "hot spot" in the duodenum at the same location as the esd performed in (b)(6) 2021.It was stated that the physician attributed this finding to orise inflammation.As a result of the findings on the pet scan, the patient underwent an esophagogastroduodenoscopy (egd) procedure with biopsy in (b)(6) 2022.The biopsy showed "peptic duodenitis with ulceration".

• Brand Name: ORISE GEL
• Common Device Name: 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: 15655131
• Report Number: 3005099803-2022-06082
• Device Sequence Number: 17651353
• Product Code: PLL
• UDI-Device Identifier: 08714729993841
• UDI-Public: 08714729993841
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K180068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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
• Operator of Device: Health Professional
• Device Model Number: M00519221
• Device Catalogue Number: 2202-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92926415-FA
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown