INTELLANAV STABLEPOINT Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared Feb 2016 · 2 device variants grouped
Total Reports
455
Reports (30d)
2
Active Signals
1
Open Recalls
7
What the reports describe · Claripulse analysis
Most commonly reported problems
Irrigation Delivery Issue with Catheter
pebax, qdot micro, patient underwent, qdot, index
3
reports
Inconsistent Irrigation Flow During Ablation
observed, thermocool, ablation procedure, patients, study
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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
Characteristics and optimal ablation settings of a novel, contact‐force sensing and local impedance‐enabled catheter in an ex vivo perfused swine ventricle model
Kenta Tsutsui, et al. · Journal of Cardiovascular Electrophysiology · 2021
Prospective evaluation of local impedance drop to guide left atrial posterior wall ablation with high power
Francesco Solimene, et al. · Journal of Interventional Cardiac Electrophysiology · 2022
Pulsed field ablation using focal contact force-sensing catheters for treatment of atrial fibrillation: acute and 90-day invasive remapping results
Ante Anić, et al. · EP Europace · 2023
Pulsed Field Ablation Using Focal Contact Force–Sensing Catheters for Treatment of Atrial Fibrillation: 1-Year Outcomes of the ECLIPSE AF Study
Ante Anić, et al. · Circulation Arrhythmia and Electrophysiology · 2024
Improved Ablation Efficiency in PVI Guided by Contact Force and Local Impedance: Chronic Canine Model
Sarah R. Gutbrod, et al. · Frontiers in Physiology · 2022
Citations indexed from PubMed.
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