Arctic Front Advance Pro Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared Dec 2010
Total Reports
1,722
Reports (30d)
14
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Balloon Catheter Vacuum Leak During Cryoablation
umbilical, cryoablation, completed cryo, balloon catheter, result event
21
reports
Cardiac Tamponade from Micro Catheter Use
micro catheter, micro, qdot micro, used, qdot
1
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
Ablation of Atrial Fibrillation Using the fourth-generation Cryoballoon Arctic Front Advance PRO
Erik Wißner · Future Cardiology · 2020
Outcomes after cryoballoon ablation of paroxysmal atrial fibrillation with the PolarX or the Arctic Front Advance Pro: a prospective multicentre experience
Nikita Tanese, et al. · EP Europace · 2023
Comparative efficacy and safety of POLARx versus Arctic front advance pro cryoballoon systems for pulmonary vein isolation in atrial fibrillation: an updated systematic review and meta-analysis.
Tahir MF, et al. · Frontiers in cardiovascular medicine · 2025
Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation
Jonathan P. Piccini, et al. · Heart Rhythm O2 · 2020
Difference in tissue temperature change between two cryoballoons
Takahiro Hayashi, et al. · Open Heart · 2023
Citations indexed from PubMed.
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