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

Model Number M00519221

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 04/01/2022

Event Type  Injury  

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 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".

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 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
• 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: 15655131
• MDR Text Key: 302247423
• Report Number: 3005099803-2022-06082
• Device Sequence Number: 1
• Product Code: PLL
• UDI-Device Identifier: 08714729993841
• UDI-Public: 08714729993841
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180068
• 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: 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
• Device Operator: Health Professional
• Device Model Number: M00519221
• Device Catalogue Number: 2202-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 11/23/2022
• 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