Arctic Front Advance Pro Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared May 2018 · 2 device variants grouped
Total Reports
1,733
Reports (30d)
0
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Balloon Catheter Handle Blood Detection
coaxial umbilical, cryo, balloon, coaxial, balloon catheter
14
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
Mar 4, 2019 · Open, Classified
The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
Evidence
Related research
Feasibility and safety of left atrial posterior wall isolation with a new Cryoballoon technology in patients with persistent atrial fibrillation.
Bisignani A, et al. · Pacing and clinical electrophysiology : PACE · 2022
The established and the challenger: A direct comparison of current cryoballoon technologies for pulmonary vein isolation.
Moser F, et al. · Journal of cardiovascular electrophysiology · 2021
Citations indexed from PubMed.
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