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Epistaxis

Epistaxis

Epistaxis, or nosebleeds, occurs when small, swollen blood vessels in the nasal mucous membrane rupture. Typically, the anterior septum is the primary site of occurrence.
Etiology
Possible causes of this condition include high blood pressure, trauma, low humidity, upper respiratory tract infections, allergies, foreign bodies, nasal inhalation of corticosteroids or illicit drugs, excessive use of decongestant nasal sprays, facial or nasal surgery, anatomic malformation, tumors, or systemic...

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Nasal Epistaxis Balloons: A Comprehensive MAUDE Database Analysis.

Tyler B Merrill¹, Christopher D Pool², Robert A Saadi¹

¹Department of Otolaryngology - Head and Neck Surgery, University of Arkansas for Medical Sciences, USA.

American Journal of Otolaryngology

|October 20, 2023

Summary

This summary is machine-generated.

Nasal epistaxis balloons, while common, have associated risks. A review of adverse events revealed serious complications including death, device failure, and internal injuries, highlighting the need for increased provider and patient awareness.

Keywords:

Adverse event Epistaxis MAUDE database Nasal balloon Patient safety Risk profile

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Area of Science:

Otolaryngology
Medical Device Safety
Patient Outcomes

Background:

Nasal epistaxis balloons are widely used for nosebleed control.
The safety profile and complication rates of these devices are not well-established.

Purpose of the Study:

To analyze adverse events associated with nasal epistaxis balloons using the FDA MAUDE database.
To identify and categorize complications to improve clinical practice and patient counseling.

Main Methods:

Medical Device Reports (MDRs) for nasal epistaxis balloons were queried from the FDA MAUDE database.
Data from January 2012 to November 2022 were reviewed and categorized for device-related and patient-related events.

Main Results:

Out of 19 reports, 5 (26.3%) were device-related (e.g., leaks, breakage).
14 reports (73.7%) were patient-related, including two deaths from exsanguination.
Other severe events included bowel perforation, CSF leak, intracranial placement, and respiratory distress.

Conclusions:

Nasal epistaxis balloons, despite general safety perception, have documented severe adverse events.
Awareness of these complications is crucial for informed consent and clinical decision-making.
Further investigation into device design and usage protocols may mitigate risks.