Ahmed Khalid, Abdallah Mohamed, Abbas Daniyal, Jaber Fouad, Abdalla Abubaker O, Mohamed Mouhand, McDonald Nicholas, Hanson Brian J, Bilal Mohammad
Department of Internal Medicine, The Wright Center for Graduate Medical Education, Scranton, PA.
Department of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, University of Minnesota.
J Clin Gastroenterol. 2024 Apr 1;58(4):402-406. doi: 10.1097/MCG.0000000000001859.
Topical hemostatic powder is a mineral powder that forms an adherent barrier and coagulates active bleeding in the gastrointestinal (GI) tract. Hemospray is the first hemostatic powder approved by the Food and Drug Administration (FDA) in the United States. Hemospray has been increasingly used to manage GI 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" database.
We analyzed the postmarketing surveillance data from the FDA's Manufacturer and User Facility Device Experience database for Hemospray, initially known as TC-325, from June 2018 through April 2022. Results of the search were classified into device-related technical issues, patient-related adverse events and health care staff-related adverse events.
Five hundred two medical device reporting claims were identified from June 2018 through April 2022. Seven duplicate claims were identified, and some claims included more than one event type. Therefore, there were 558 device-related problems, 28 patient-related adverse events, and 2 adverse events in health care staff members. The most common device-related problems were activation failure or failure to fire (n = 385, 70.0%) and obstruction of carbon dioxide flow (n = 121, 21.7). The most common patient-related adverse events included tissue injury or bleeding (n = 21) and perforation (n = 5).
Although Hemospray is a valuable tool in the armamentarium for endoscopists in managing GI bleeding, endoscopists must be mindful of deice-related problems and potential patient-related adverse events.
局部止血粉是一种矿物粉末，可形成粘附屏障并使胃肠道（GI）内的活动性出血凝固。Hemospray是美国食品药品监督管理局（FDA）批准的首款止血粉。Hemospray已越来越多地用于治疗胃肠道出血。然而，关于止血粉不良事件的数据却很缺乏。因此，我们旨在使用FDA的“制造商和用户设施设备经验”数据库报告并分析与Hemospray相关的不良事件。
我们分析了FDA的制造商和用户设施设备经验数据库中关于Hemospray（最初称为TC-325）在2018年6月至2022年4月期间的上市后监测数据。搜索结果分为与设备相关的技术问题、与患者相关的不良事件和与医护人员相关的不良事件。
在2018年6月至2022年4月期间共识别出502份医疗器械报告索赔。识别出7份重复索赔，有些索赔包含不止一种事件类型。因此，有558个与设备相关的问题、28个与患者相关的不良事件以及2个医护人员的不良事件。最常见的与设备相关的问题是激活失败或无法发射（n = 385，70.0%）以及二氧化碳流阻塞（n = 121，21.7）。最常见的与患者相关的不良事件包括组织损伤或出血（n = 21）和穿孔（n = 5）。
尽管Hemospray是内镜医师治疗胃肠道出血的有用工具，但内镜医师必须注意与设备相关的问题以及潜在的与患者相关的不良事件。
