POLARx Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared Aug 2023 · 2 device variants grouped
Total Reports
234
Reports (30d)
0
Active Signals
0
Open Recalls
7
What the reports describe · Claripulse analysis
Most commonly reported problems
Balloon Catheter Handle Blood Detection
coaxial umbilical, cryo, balloon, coaxial, balloon catheter
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Oct 10, 2024 · Open, Classified
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Oct 10, 2024 · Open, Classified
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Oct 10, 2024 · Open, Classified
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Oct 10, 2024 · Open, Classified
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Oct 10, 2024 · Open, Classified
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Oct 10, 2024 · Open, Classified
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Evidence
Related research
Atrial fibrillation cryoablation is an effective day case treatment: the UK PolarX vs. Arctic Front Advance experience
Shohreh Honarbakhsh, et al. · EP Europace · 2023
PolarX vs Arctic Front for Cryoballoon Ablation of Paroxysmal AF: The Randomized COMPARE CRYO Study.
Reichlin T, et al. · JACC. Clinical electrophysiology · 2024
Initial clinical experience with the novel POLARx FIT cryoballoon system for pulmonary vein isolation in patients with atrial fibrillation.
Fukunaga H, et al. · International journal of cardiology. Heart & vasculature · 2023
Outcomes after cryoballoon ablation of paroxysmal atrial fibrillation with the PolarX or the Arctic Front Advance Pro: a prospective multicentre experience.
Tanese N, et al. · 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
PolarX Cryoballoon metrics predicting successful pulmonary vein isolation: targets for ablation of atrial fibrillation
Shohreh Honarbakhsh, et al. · EP Europace · 2022
Citations indexed from PubMed.
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