Singh Amrita K, Kasle David A, Torabi Sina J, Manes R Peter
Division of Otolaryngology, Yale University School of Medicine, New Haven, Connecticut, USA.
Otolaryngol Head Neck Surg. 2021 Oct;165(4):597-601. doi: 10.1177/0194599820986581. Epub 2021 Feb 2.
Posterior nasal nerve (PNN) cryoablation is a novel surgical technique used to address chronic rhinitis. The purpose of this study is to review the medical device reports (MDRs) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events related to the use of ClariFix, a device designed for office-based cryosurgical ablation of the PNN. A total of 12 adverse events associated with ClariFix from January 2017 to August 2020 were identified and analyzed. The most common adverse events associated with ClariFix PNN cryoablation include epistaxis and nasal swelling. Further studies are needed to clarify whether PNN cryoablation is associated with epistaxis in certain populations.
鼻后神经（PNN）冷冻消融术是一种用于治疗慢性鼻炎的新型外科技术。本研究的目的是回顾提交给美国食品药品监督管理局（FDA）的制造商和用户设备设施经验（MAUDE）数据库的医疗器械报告（MDR），以识别与ClariFix使用相关的不良事件，ClariFix是一种设计用于门诊冷冻手术消融PNN的设备。共识别并分析了2017年1月至2020年8月期间与ClariFix相关的12起不良事件。与ClariFix PNN冷冻消融术相关的最常见不良事件包括鼻出血和鼻肿胀。需要进一步研究以阐明PNN冷冻消融术在某些人群中是否与鼻出血有关。
