C0292 - Analysis of Reported Adverse Events Related to Hemospray: A MAUDE Database Analysis

Khalid Ahmed, MD¹, Mohamed Abdallah, MD², Daniyal Abbas, MD³, Abubaker Abdalla, MD⁴, Gaurav Suryawanshi, MD², Nicholas McDonald, MD⁵, Shifa Umar, MD⁶, Mouhand F. Mohamed, MD, MSc⁷, Brian Hanson, MD⁸, Mohammad Bilal, MD^9
1The Wright Center for GME, Scranton, PA; ²University of Minnesota Medical Center, Minneapolis, MN; ³East Carolina University, Greenville, NC; ⁴Emory University, Atlanta, GA; ⁵University of Minnesota, Minneapolis, MN; ⁶Mayo Clinic, Rochester, MN; ⁷Warren Alpert Medical School of Brown University, Providence, RI; ⁸Minneapolis Veterans Affairs Health Care System, Minneapolis, MN; ⁹University of Minnesota, Minneapolis VA Medical Center, Minneapolis, MN

Introduction: Topical hemostatic powder is a highly absorptive, inert mineral powder that forms an adherent mechanical barrier and coagulates active bleeding in the gastrointestinal tract. Hemospray is the only hemostatic powder which has been approved by the Food and Drug Administration (FDA) in the United States. Since its approval in May 2018, Hemospray has been increasingly used to manage upper and lower gastrointestinal bleeding. However, data on the adverse events of hemostatic powders are lacking. Therefore, we aim to report and analyze adverse events associated with Hemospray using the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database.

Methods: We analyzed the post-marketing surveillance data from the FDA MAUDE database for Hemospray, initially known as TC-325 from June 2018 through April 2022.

Results: Four hundred ninety medical device reporting claims were identified from June 2018 through April 2022. There were two duplicates, and 488 claims were analyzed. There were 475 device-related problems, eleven patient-related adverse events, and two adverse events in healthcare staff members. The most common device-related problems were activation failure or failure to fire (n=373, 78.5%), obstruction of carbon dioxide (CO2) flow (n=42, 8.8%), inability to remove the Hemospray from the endoscope (n=18, 3.8%), device fracture (n=10, 2.1%), CO2 leak (n=9, 1.9%), defective Hemospray device (n=5, 1.1%) and explosion (n=2, 0.42%).

180 out of these 475 device-related problems were reported on the same adverse event claim. The most common combination claim was activation failure or failure to fire and obstruction of CO² flow. Patient-related adverse events included perforation (n=5), unspecified tissue injury or bleeding (n=3), allergic reaction (n=1), failure of removal of hemospray (n=1), and infection (cholangitis) from the use of Hemospray in the bile duct (n=1). In addition, two events healthcare staff reported chest tightness/pain after inhaling Hemospray particles.

Discussion: While Hemospray is a useful tool in the armamentarium for endoscopists in the management of gastrointestinal bleeding, it is important for endoscopists to be mindful of these adverse events and device related issues. Activation failure or failure to fire and perforation are the most common device- and patient-related adverse events.


Disclosures:


Khalid Ahmed, MD¹, Mohamed Abdallah, MD², Daniyal Abbas, MD³, Abubaker Abdalla, MD⁴, Gaurav Suryawanshi, MD², Nicholas McDonald, MD⁵, Shifa Umar, MD⁶, Mouhand F. Mohamed, MD, MSc⁷, Brian Hanson, MD⁸, Mohammad Bilal, MD⁹. C0292 - Analysis of Reported Adverse Events Related to Hemospray: A MAUDE Database Analysis, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.