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Patient Safety and Quality Improvement

(327) Nasal Epistaxis Balloons: A Comprehensive Analysis of the MAUDE Database

Monday, October 2, 2023
2:45 PM – 3:45 PM East Coast USA Time
Has Audio

    Presenting Author(s)

  • TM

    Tyler B. Merrill, MD

    Fellow
    Cleveland Clinic Foundation
    Cleveland, Ohio, United States

    • Co-Author(s)

  • CP

    Christopher D. Pool, MD

    Associate
    ENT and Allergy Specialists
    Phoenixville, Pennsylvania, United States

  • RS

    Robert A. Saadi, MD

    Resident Physician
    University of Arkansas for Medical Sciences
    Little Rock, Arkansas, United States

    • Senior Author(s)

  • Vijay A. Patel, MD

    Associate Physician
    University of California San Diego
    San Diego, CA, United States

Disclosure(s):
Tyler B. Merrill, MD: No relevant relationships to disclose.
Christopher D. Pool, MD: No relevant relationships to disclose.
Robert A. Saadi, MD: No relevant relationships to disclose.
Vijay A. Patel, MD: No relevant relationships to disclose.


Introduction: 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. 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 their use.

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. 28 MDR were identified, 19 of which met inclusion criteria. Reports were individually tabulated, and events were categorized with special attention to AEs.

Results: During the study time period, 19 MDRs met inclusion criteria. 5 MDRs were classified as device related (26.3%). Two events were reported for balloon leak and deflation and two others were reported for the device breaking apart. One device related MDR was unknown. 14 MDRs (73.7%) were classified as patient related. Of significant concern was that two MDRs documented 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=2).

Conclusions: Though epistaxis control with nasal balloons is generally seen as a safe procedure, there have been several concerning AEs reported over the past decade. While two reports of death due to exsanguination were the most severe AEs, multiple other life-threatening AEs were also seen. Use of nasal balloons to control acute epistaxis is widespread across multiple practice settings, so an 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 in the management of acute epistaxis. Future studies with standardized reporting protocols are warranted to create a central registry for nasal balloon utilization to further investigate root causes of associated complications.