PulseSelect Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Cardiac Ablation Catheter (Pulsed Field/PFA) · First cleared Dec 2023 · 7 device variants grouped
Total Reports
2,164
Reports (30d)
103
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Vagal Response Inducing Heart Block
heart block, vagal response, procedure vagal, response observed, complete heart
73
reports
Cable Connection Issue with Residue
cable, substance, procedure catheter, completed pulsed, connection
30
reports
Kinked Catheter Shaft During Insertion
guidewire, procedure catheter, tip, completed pulsed, resolved issue
28
reports
Incomplete Cable Connection with Foreign Material
procedure catheter, completed pulsed, connection, fully, cable
18
reports
Post-Ablation Atrial Fibrillation Recurrence
related, days, rhythm, tachycardia, sinus rhythm
14
reports
Deformed Catheter Ring During Removal
procedure catheter, guidewire, tip, inferior pulmonary, completed cardiac
13
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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