Advisor HD Grid, Sensor Enabled Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · Catheter, Electrode Recording (EP Diagnostic) · First cleared Apr 2018
Total Reports
414
Reports (30d)
1
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Broken Mapping Catheter Before Procedure
broken, cryo, cryo ablation, electrodes, removal
2
reports
Pericardial Effusion from Catheter Kinking
pericardial effusion, decanav catheter, pericardial, effusion, decanav
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
High-Power Short-Duration Posterior Wall Isolation in Addition to Pulmonary Vein Isolation in Persistent Atrial Fibrillation Ablation Using the New TactiFlex™ Ablation Catheter
Sergio Conti, et al. · Journal of Cardiovascular Development and Disease · 2024
Safety of conscious sedation in electroanatomical mapping procedures and cryoballoon pulmonary vein isolation
Karolina Weinmann, et al. · Heart and Vessels · 2020
Hybrid convergent procedure with proactive oesophageal cooling for the treatment of long-standing persistent atrial fibrillation: a case series
Alejandro Velasco, et al. · European Heart Journal - Case Reports · 2024
How to ablate the septo-pulmonary bundle: a case-based review of percutaneous ablation strategies to achieve roof line block
Johanna Tonko, et al. · EP Europace · 2023
Procedural and outcome impact of obesity in cryoballoon versus radiofrequency pulmonary vein isolation in atrial fibrillation patients
C Scheurlen, et al. · Journal of Interventional Cardiac Electrophysiology · 2022
Citations indexed from PubMed.
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