{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,5]],"date-time":"2025-11-05T20:58:45Z","timestamp":1762376325208,"version":"build-2065373602"},"reference-count":16,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2017,12,12]],"date-time":"2017-12-12T00:00:00Z","timestamp":1513036800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["aao-hnsfjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Otolaryngol.--head neck surg."],"published-print":{"date-parts":[[2018,2]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>The rate of balloon dilator failure is unknown, and a rescue strategy for device malfunction has not been established. The purposes of this investigation were to determine the approximate number of balloon failures in the gastrointestinal tract and airway, evaluate the parameters required to rupture balloon dilators, and develop a rescue strategy to efficiently reestablish airway patency.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design<\/jats:title><jats:p>Retrospective cohort and basic medical research.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Academic tertiary care medical center.<\/jats:p><\/jats:sec><jats:sec><jats:title>Subjects and Methods<\/jats:title><jats:p>The Manufacturer and User Facility Device Experience database was queried for adverse events associated with tracheal and esophageal dilators between January 1, 2014, and January 1, 2017. A bench\u2010top model of airway stenosis was developed, and optimal conditions for the safe removal of a malfunctioning dilator were assessed (2, 4, 6 atm).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>There were 420 reported balloon malfunctions, including 104 cases with deflation\/removal issues. The bench\u2010top model determined that device rupture allowing for immediate removal occurs with needle puncture at balloon pressures \u22658 atm. Balloons inflated to 6 atm required a median of 17.5\u00a0seconds (range, 0\u201055.3) for removal, in comparison with 30.2\u00a0seconds (range, 7.1\u201087.5) at 2 atm (<jats:italic>P<\/jats:italic> &gt;. 05).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Balloon dilator malfunction is a significant problem that practitioners must be prepared for. Pressure \u22658 atm (~33% overinflation) is required to consistently cause complete balloon dilator rupture via needle puncture. While counterintuitive, increasing the inflation pressure of a malfunctioning balloon (8\u201010 atm) may expedite rupture and safe removal. A rescue strategy for balloon malfunction is proposed.<\/jats:p><\/jats:sec>","DOI":"10.1177\/0194599817742356","type":"journal-article","created":{"date-parts":[[2017,12,13]],"date-time":"2017-12-13T04:02:33Z","timestamp":1513137753000},"page":"331-336","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Analysis of Reported Balloon Malfunctions and Proposed Rescue Strategy for Malfunction during Airway Dilation"],"prefix":"10.1002","volume":"158","author":[{"given":"E. Brandon","family":"Strong","sequence":"first","affiliation":[{"name":"Center for Voice and Swallowing Department of Otolaryngology\u2013Head and Neck Surgery University of California\u2013Davis Sacramento California USA"},{"name":"Department of Biological Sciences California Polytechnic State University San Luis Obispo California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Derrick R.","family":"Randall","sequence":"additional","affiliation":[{"name":"Center for Voice and Swallowing Department of Otolaryngology\u2013Head and Neck Surgery University of California\u2013Davis Sacramento California USA"},{"name":"Section of Otolaryngology\u2013Head and Neck Surgery Department of Surgery University of Calgary Calgary Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel J.","family":"Cates","sequence":"additional","affiliation":[{"name":"Center for Voice and Swallowing Department of Otolaryngology\u2013Head and Neck Surgery University of California\u2013Davis Sacramento California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter C.","family":"Belafsky","sequence":"additional","affiliation":[{"name":"Center for Voice and Swallowing Department of Otolaryngology\u2013Head and Neck Surgery University of California\u2013Davis Sacramento California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,12,12]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/000348940811700201"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2011.348"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1080\/17474124.2017.1260002"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1051-0443(07)61774-6"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.mlg.0000228006.21941.12"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.sempedsurg.2016.02.006"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/00020840-200312000-00011"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1378\/chest.112.4.1136"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/archoto.2011.1439"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1177\/000348941312200603"},{"key":"e_1_2_9_12_1","unstructured":"MAUDE adverse event report: Boston Scientific CRE Wireguided Dilator.Manufacturer and User Facility Device Experience database (Food and Drug Administration). Report 3005099803\u20102014\u201003291.https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfmaude\/detail.cfm?mdrfoi__id=4134866pc=KNQ. Published2014. Accessed June 2017."},{"key":"e_1_2_9_13_1","unstructured":"MAUDE adverse event report: Boston Scientific CRE Fixed Wire Dilator.Manufacturer and User Facility Device Experience database (Food and Drug Administration). Report 3005099803\u20102015\u201002230.https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfmaude\/detail.cfm?mdrfoi__id=4992422pc=KNQ. Published2015. Accessed June 2017."},{"key":"e_1_2_9_14_1","unstructured":"MAUDE adverse event report: Boston Scientific CRE Fixed Wire Dilator.Manufacturer and User Facility Device Experience database (Food and Drug Administration). Report 3005099803\u20102016\u201003128.https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfmaude\/detail.cfm?mdrfoi__id=6045642pc=KNQ. Published2016. 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