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POLARx Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared Aug 2023

Total Reports

234

Reports (30d)

1

Active Signals

0

Open Recalls

7

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Balloon Catheter Vacuum Leak During Cryoablation

umbilical, cryoablation, completed cryo, balloon catheter, result event

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

Class I

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.

Class I

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.

Class I

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.

Class I

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.

Class I

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.

Class I

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

PolarX vs Arctic Front for Cryoballoon Ablation of Paroxysmal AF

Tobias Reichlin, et al. · JACC. Clinical electrophysiology · 2024

PolarX Cryoballoon metrics predicting successful pulmonary vein isolation: targets for ablation of atrial fibrillation

Shohreh Honarbakhsh, et al. · EP Europace · 2022

News from the Cold Chamber: Clinical Experiences of POLARx versus Arctic Front Advance for Single-Shot Pulmonary Vein Isolation

Denise Guckel, et al. · Journal of Cardiovascular Development and Disease · 2022

Initial clinical experience with the novel POLARx FIT cryoballoon system for pulmonary vein isolation in patients with atrial fibrillation

Hiroshi Fukunaga, et al. · IJC Heart & Vasculature · 2023

Atrial fibrillation cryoablation is an effective day case treatment: the UK PolarX vs. Arctic Front Advance experience

Shohreh Honarbakhsh, et al. · EP Europace · 2023

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.