MEDTRONIC, INC. · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared Dec 2010
Total Reports
1,667
Reports (30d)
7
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
High Force Reading with Pericardial Effusion
micro, qdot micro, pericardial, effusion, qdot
23
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Mar 4, 2019 · Open, Classified
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
Evidence
Feasibility and safety of left atrial posterior wall isolation with a new Cryoballoon technology in patients with persistent atrial fibrillation
Antonio Bisignani, et al. · Pacing and Clinical Electrophysiology · 2022
Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation
Jonathan P. Piccini, et al. · Heart Rhythm O2 · 2020
The established and the challenger: A direct comparison of current cryoballoon technologies for pulmonary vein isolation
Fabian Moser, et al. · Journal of Cardiovascular Electrophysiology · 2021
Use of a novel integrated dilator-needle system in cryoballoon procedures: a zero-exchange approach
Sing‐Chien Yap, et al. · Journal of Interventional Cardiac Electrophysiology · 2022
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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