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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.
Background:
While nasal epistaxis balloons are generally seen as safe and routinely utilized by both surgical and nonsurgical providers, the complication profile related to this type of device has not been well defined.
Objective:
The objective of this study was to utilize the FDA MAUDE (Manufacturer and User Facility Device Experience) database to better assess adverse events (AE) related to use of nasal epistaxis balloons. Reports were individually tabulated and events were categorized with special attention to AEs.
Methods:
The FDA MAUDE database was queried for all medical device reports (MDR) related to nasal epistaxis balloon devices from January 2012 to November 2022.
Results:
19 MDRs met inclusion criteria. 5 MDRs were classified as device related (26.3 %); two events were reported for balloon leak and deflation, two events were reported for device breakage, and one device related event was unknown. 14 MDRs (73.7 %) were classified as patient related. Two documented MDRs were patient deaths due to exsanguination. Additional serious AEs included balloon ingestion and subsequent small bowel perforation (n = 1), cerebrospinal fluid leak (n = 1), skull base violation and intracranial placement of the device (n = 1), and respiratory distress (n = 3).
Conclusion:
Though epistaxis control with nasal balloons is generally seen as a safe procedure, there have been several concerning AEs reported. While two reports of death due to exsanguination were the most severe AEs, multiple other life-threatening AEs were also documented. Increased awareness of associated complications can be used to better counsel patients during the informed consent process as well as providers in their clinical decision making.
Insights
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.
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.
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