PulseSelect Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Cardiac Ablation Catheter (Pulsed Field/PFA) · First cleared Dec 2023
Total Reports
1,785
Reports (30d)
115
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Catheter Shaft Detachment During Procedure
catheter replaced, completed pulsed, issue case, cardiac ablation, array
143
reports
Vagal Response Causing Bradycardia
unknown patient, bradycardia, vagal response, response observed, result event
77
reports
Pericardial Effusion with Blood Pressure Drop
blood pressure, pericardial effusion, cardiac ablation, pericardial, result event
25
reports
Coronary Spasm During Ablation
coronary, cardiac ablation, spasm, elevation, result event
11
reports
Phrenic Nerve Injury Post-Ablation
cardiac ablation, flow, irrigation, high, result event
6
reports
Stroke Following High Temperature Error
stroke, cardiac ablation, acute, magnetic, result event
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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