Adverse Events Associated With ClariFix Posterior Nasal Nerve Cryoablation: A MAUDE Database Analysis
Amrita K Singh1, David A Kasle1, Sina J Torabi1
1Division of Otolaryngology, Yale University School of Medicine, New Haven, Connecticut, USA.
Abstract:
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.
Insights
Posterior nasal nerve (PNN) cryoablation using ClariFix for chronic rhinitis can cause epistaxis and nasal swelling. Further research is needed to understand PNN cryoablation
Area of Science:
- Otolaryngology
- Medical Device Safety
- Surgical Innovation
Background:
- Chronic rhinitis affects millions, impacting quality of life.
- Posterior nasal nerve (PNN) cryoablation is an emerging treatment.
- ClariFix is an office-based device for PNN cryosurgical ablation.
Purpose of the Study:
- To analyze adverse events associated with ClariFix device use.
- To identify safety concerns from FDA Manufacturer and User Device Facility Experience (MAUDE) database reports.
Main Methods:
- Retrospective review of Medical Device Reports (MDRs) in the FDA MAUDE database.
- Analysis of 12 adverse events linked to ClariFix from January 2017 to August 2020.
Main Results:
- Epistaxis (nosebleeds) was a common adverse event.
- Nasal swelling was another frequently reported adverse event.
- 12 adverse events were identified and analyzed.
Conclusions:
- ClariFix PNN cryoablation is associated with epistaxis and nasal swelling.
- Further investigation is required to determine PNN cryoablation's specific risks for epistaxis in different patient groups.
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