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 Arrhythmia (1721); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Boston scientific became aware of an event involving orise gel through the article, optimal submucosal injection for submucosal dissection: a single-center experience, by sera satoi, et al.Per literature, the primary outcome of this study was the amount of each agent used to achieve adequate submucosal lifting.Secondary outcomes included resection rates, endoscopic submucosal dissection (esd) times, length of hospital stay, and adverse events.90 patients who underwent esd were included in the retrospective study, 36 of which were included in the orise gel group.Adverse events mentioned in the article included delayed bleeding, infection, hypotension, and arrythmia with no additional information.While it is noted that these adverse events occurred in subjects who were in the orise gel group, it is unknown if there is a relationship to the use of orise gel.

Manufacturer Narrative

Block a2: patients' exact ages are unknown as it is unknown which patients experienced the reported adverse events; however, the median age of the 36 patients that had orise gel was 64 (56.3 -73).Block a3: patients' genders are unknown as it is unknown which patients experienced the reported adverse events; however, of the 36 patients that had orise gel 18 were female and 18 were male.Block b3: approximated based on the date the article was published.Block d4, h4: the device upn and lot number are unknown; therefore, the lot expiration and device manufacture dates are unknown.Block g2: literature source satoi, sera md; nishimura, makoto md; chin, kana md; beauvais, jacques c.Md; schattner, mark md.S1124 optimal submucosal injection for submucosal dissection: a single-center experience.The american journal of gastroenterology 117(10s);p e819, 2022.Doi: 10.14309/01.Ajg.0000861136.62502.6f.

• 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: 17939715
• MDR Text Key: 325736059
• Report Number: 3005099803-2023-05514
• 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: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/16/2023

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: 09/21/2023
• Initial Date FDA Received: 10/16/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other