{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T15:58:39Z","timestamp":1790697519051,"version":"4.1.0"},"reference-count":21,"publisher":"IMR Press","issue":"9","license":[{"start":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T00:00:00Z","timestamp":1789084800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Rev. Cardiovasc. Med."],"abstract":"<jats:p>Background: Pulsed field ablation (PFA) is Food and Drug Administration (FDA)-cleared for pulmonary vein isolation in atrial fibrillation. Using a keyword-based natural language processing pipeline applied to free-text narratives in the FDA MAUDE database, we aimed to characterize and compare adverse event and device malfunction profiles across the four cleared PFA systems. Methods: We retrieved 6930 MAUDE reports for FDA product code QZI (pulsed field ablation catheter) spanning December 13, 2023 through April 30, 2026, covering all four FDA-cleared PFA systems. Reports were deduplicated and assigned to a specific device system using manufacturer and brand name fields. Concatenated free-text narratives were classified into 11 predefined adverse event categories using multi-label keyword-based natural language processing. Device malfunction reports were additionally subclassified into one of 11 hardware-specific subtypes. Descriptive statistics were used throughout. Results: Of 6930 reports, 4185 (60.4%) were classified into at least one adverse event category. The three most common categories were device\/catheter malfunction (2068; 29.8%), cardiac tamponade\/pericardial effusion (915; 13.2%), and stroke\/TIA\/cerebral embolism (600; 8.7%). PFA-specific physiologic adverse events\u2014ST-elevation myocardial infarction (STEMI), hemolysis\/acute kidney injury, and phrenic nerve palsy\u2014accounted for 615 combined reports (8.9% of all reports). Fatality proportions were highest for vascular access complications (6.8%), esophageal\/atrioesophageal injury (6.0%), and coronary artery spasm\/STEMI (5.3%). Among malfunction reports, retraction\/retrieval failure predominated for Farapulse (48.9%), while electrical\/energy delivery failure was the leading subtype for PulseSelect (29.4%). Conclusions: Natural language processing (NLP)-assisted keyword classification enables systematic, scalable characterization of adverse event patterns across nearly 7000 real-world PFA reports. PFA-specific physiologic adverse events are identifiable through post-market surveillance data and constitute a distinct safety phenotype separate from device malfunction. This approach provides a reproducible framework for near-real-time surveillance of novel cardiac ablation systems.<\/jats:p>","DOI":"10.31083\/rcm53385","type":"journal-article","created":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T14:57:11Z","timestamp":1790693831000},"source":"Crossref","is-referenced-by-count":0,"title":["Adverse Event Landscape of Pulsed Field Ablation Catheters: A Computational Review of FDA MAUDE Post-Market Surveillance Data"],"prefix":"10.31083","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6100-0897","authenticated-orcid":true,"given":"Matthew W.","family":"Segar","sequence":"first","affiliation":[{"name":"Department of Cardiology, Texas Heart Institute, Houston, TX 77030, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4431-2474","authenticated-orcid":true,"given":"Kaleb D.","family":"Lambeth","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Texas Heart Institute, Houston, TX 77030, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3909-154X","authenticated-orcid":true,"given":"Shyon","family":"Parsa","sequence":"additional","affiliation":[{"name":"Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehdi","family":"Razavi","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Texas Heart Institute, Houston, TX 77030, USA"},{"name":"Department of Cardiology, Baylor College of Medicine, Houston, TX 77030, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"16242","published-online":{"date-parts":[[2026,9,11]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","unstructured":"Reddy VY, Calkins H, Mansour M, Wazni O, Di Biase L, Bahu M, et al. Pulsed Field Ablation to Treat Paroxysmal Atrial Fibrillation: Safety and Effectiveness in the AdmIRE Pivotal Trial. Circulation. 2024; 150: 1174\u20131186.","DOI":"10.1161\/CIRCULATIONAHA.124.070333"},{"key":"ref2","doi-asserted-by":"publisher","unstructured":"Reddy VY, Gerstenfeld EP, Natale A, Whang W, Cuoco FA, Patel C, et al. Pulsed Field or Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation. The New England Journal of Medicine. 2023; 389: 1660\u20131671.","DOI":"10.1056\/NEJMoa2307291"},{"key":"ref3","doi-asserted-by":"publisher","unstructured":"Verma A, Haines DE, Boersma LV, Sood N, Natale A, Marchlinski FE, et al. Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial. Circulation. 2023; 147: 1422\u20131432.","DOI":"10.1161\/CIRCULATIONAHA.123.063988"},{"key":"ref4","unstructured":"U.S. Food and Drug Administration. Premarket Approval P230017: PulseSelect Pulsed Field Ablation System. 2024. Available at: https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpma\/pma.cfm?id=P240006 (Accessed: 17 January 2026)."},{"key":"ref5","unstructured":"U.S. Food and Drug Administration. Premarket Approval P230030: FARAPULSE Pulsed Field Ablation System. 2024. Available at: https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpma\/pma.cfm?id=P230030 (Accessed: 17 January 2026)."},{"key":"ref6","unstructured":"U.S. Food and Drug Administration. Premarket Approval P240013: Sphere-9 Catheter with Affera Mapping and Ablation System. 2024. Available at: https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpma\/pma.cfm?id=P240013 (Accessed: 17 January 2026)."},{"key":"ref7","unstructured":"U.S. Food and Drug Administration. Premarket Approval P240006: VARIPULSE Pulsed Field Ablation Catheter. 2024. Available at: https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpma\/pma.cfm?id=P240006 (Accessed: 17 January 2026)."},{"key":"ref8","doi-asserted-by":"publisher","unstructured":"Malyshev Y, Neuzil P, Petru J, Funasako M, Hala P, Kopriva K, et al. Nitroglycerin to Ameliorate Coronary Artery Spasm During Focal Pulsed-Field Ablation for Atrial Fibrillation. JACC. Clinical Electrophysiology. 2024; 10: 885\u2013896.","DOI":"10.1016\/j.jacep.2023.12.015"},{"key":"ref9","doi-asserted-by":"publisher","unstructured":"Reddy VY, Petru J, Funasako M, Kopriva K, Hala P, Chovanec M, et al. Coronary Arterial Spasm During Pulsed Field Ablation to Treat Atrial Fibrillation. Circulation. 2022; 146: 1808\u20131819.","DOI":"10.1161\/CIRCULATIONAHA.122.061497"},{"key":"ref10","doi-asserted-by":"publisher","unstructured":"Zhang C, Neuzil P, Petru J, Funasako M, Hala P, Kopriva K, et al. Coronary Artery Spasm During Pulsed Field vs Radiofrequency Catheter Ablation of the Mitral Isthmus. JAMA Cardiology. 2024; 9: 72\u201377.","DOI":"10.1001\/jamacardio.2023.4405"},{"key":"ref11","doi-asserted-by":"publisher","unstructured":"Mohanty S, Casella M, Compagnucci P, Torlapati PG, Della Rocca DG, La Fazia VM, et al. Acute Kidney Injury Resulting From Hemoglobinuria After Pulsed-Field Ablation in Atrial Fibrillation: Is it Preventable? JACC. Clinical Electrophysiology. 2024; 10: 709\u2013715.","DOI":"10.1016\/j.jacep.2023.12.008"},{"key":"ref12","doi-asserted-by":"publisher","unstructured":"Venier S, Vaxelaire N, Jacon P, Carabelli A, Desbiolles A, Garban F, et al. Severe acute kidney injury related to haemolysis after pulsed field ablation for atrial fibrillation. Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology: Journal of the Working Groups on Cardiac Pacing, Arrhythmias, and Cardiac Cellular Electrophysiology of the European Society of Cardiology. 2023; 26: euad371.","DOI":"10.1093\/europace\/euad371"},{"key":"ref13","doi-asserted-by":"publisher","unstructured":"Ekanem E, Neuzil P, Reichlin T, Kautzner J, van der Voort P, Jais P, et al. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. Nature Medicine. 2024; 30: 2020\u20132029.","DOI":"10.1038\/s41591-024-03114-3"},{"key":"ref14","doi-asserted-by":"publisher","unstructured":"Futela P, Kowlgi GN, DeSimone CV, Killu AM, Siontis KC, Noseworthy PA, et al. Early insights on adverse events associated with PulseSelect\u2122 and FARAPULSE\u2122: analysis of the MAUDE database. Journal of Interventional Cardiac Electrophysiology: an International Journal of Arrhythmias and Pacing. 2025; 68: 1359\u20131361.","DOI":"10.1007\/s10840-024-01935-3"},{"key":"ref15","doi-asserted-by":"publisher","unstructured":"Kass-Hout TA, Xu Z, Mohebbi M, Nelsen H, Baker A, Levine J, et al. OpenFDA: an innovative platform providing access to a wealth of FDA's publicly available data. Journal of the American Medical Informatics Association: JAMIA. 2016; 23: 596\u2013600.","DOI":"10.1093\/jamia\/ocv153"},{"key":"ref16","doi-asserted-by":"publisher","unstructured":"Cho MS, Lee SR, Black-Maier E, Jackson KP, Friedman DJ, Pokorney SD, et al. Complications associated with pulsed field ablation vs radiofrequency catheter ablation of atrial fibrillation. Heart Rhythm. 2025; 22: 2194\u20132200.","DOI":"10.1016\/j.hrthm.2024.10.063"},{"key":"ref17","doi-asserted-by":"publisher","unstructured":"Lakkireddy D, Katapadi A, Garg J, Herink E, Klotz M, Ganta J, et al. NEMESIS-PFA: Investigating Collateral Tissue Injury Associated With Pulsed Field Ablation. JACC. Clinical Electrophysiology. 2025; 11: 1747\u20131756.","DOI":"10.1016\/j.jacep.2025.04.017"},{"key":"ref18","doi-asserted-by":"publisher","unstructured":"Malyshev Y, Neuzil P, Petru J, Funasako M, Hala P, Kopriva K, et al. Does Acute Coronary Spasm From Pulsed Field Ablation Translate Into Chronic Coronary Arterial Lesions? JACC. Clinical Electrophysiology. 2024; 10: 970\u2013972.","DOI":"10.1016\/j.jacep.2024.01.007"},{"key":"ref19","doi-asserted-by":"publisher","unstructured":"Nies M, Koruth JS, Ml\u010dek M, Watanabe K, Tibensk\u00e1 VC, Kr\u00e1lovec \u0160, et al. Hemolysis After Pulsed Field Ablation: Impact of Lesion Number and Catheter-Tissue Contact. Circulation. Arrhythmia and Electrophysiology. 2024; 17: e012765.","DOI":"10.1161\/CIRCEP.124.012765"},{"key":"ref20","doi-asserted-by":"publisher","unstructured":"Shadiqa S, Iqbal M, Karwiky G, Achmad C. Phrenic nerve and esophageal injury in pulsed field ablation versus radiofrequency and cryoablation. Global Cardiology Science & Practice. 2025; 2025: e202530.","DOI":"10.21542\/gcsp.2025.30"},{"key":"ref21","doi-asserted-by":"publisher","unstructured":"Turagam MK, Neuzil P, Schmidt B, Reichlin T, Neven K, Metzner A, et al. Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry. Circulation. 2023; 148: 35\u201346.","DOI":"10.1161\/CIRCULATIONAHA.123.064959"}],"container-title":["Reviews in Cardiovascular Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.imrpress.com\/journal\/RCM\/27\/9\/10.31083\/RCM53385","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T14:58:16Z","timestamp":1790693896000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.imrpress.com\/journal\/RCM\/27\/9\/10.31083\/RCM53385"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,11]]},"references-count":21,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2026]]}},"alternative-id":["S2153-8174(26)03889-0"],"URL":"https:\/\/doi.org\/10.31083\/rcm53385","relation":{},"ISSN":["1530-6550","2153-8174"],"issn-type":[{"value":"1530-6550","type":"print"},{"value":"2153-8174","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,11]]},"article-number":"53385"}}