Electrophysiology: Ablation Adverse Event Data

Cardiac ablation catheters including AF, flutter, and pulsed-field ablation adverse event data.

Total Reports

28,068

Devices Tracked

200

Reports (30d)

646

Active Signals

103

Monthly Report Volume

Event Type Breakdown

Devices in Ablation

Device	Manufacturer	Type	Total Reports	Last 30d
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	3,866	30
FARAWAVE™QZI	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter (Pulsed Field/PFA)	3,841	116
PulseSelect™QZI	MEDTRONIC, INC.	Cardiac Ablation Catheter (Pulsed Field/PFA)	1,785	115
Arctic Front Advance Pro™OAE	MEDTRONIC, INC.	Cardiac Ablation Catheter for Atrial Fibrillation	1,696	15
TactiCath™OAE	ABBOTT (ST. JUDE MEDICAL)	Cardiac Ablation Catheter for Atrial Fibrillation	1,048	0
ThermoCool SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	1,010	0
QDOT MICROOAD	Biosense Webster Inc	Cardiac Ablation Catheter for Atrial Flutter	967	20
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	694	3
Arctic Front®OAE	MEDTRONIC, INC.	Cardiac Ablation Catheter for Atrial Fibrillation	553	2
ThermoCool SmartTouchLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	549	22
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	546	1
Sphere-9™ CatheterQZI	MEDTRONIC, INC.	Cardiac Ablation Catheter (Pulsed Field/PFA)	518	72
IntellaNav™ Open-IrrigatedOAD	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter for Atrial Flutter	511	0
Arctic Front Advance™OAE	MEDTRONIC, INC.	Cardiac Ablation Catheter for Atrial Fibrillation	510	0
INTELLANAV STABLEPOINT™OAE	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter for Atrial Fibrillation	441	3
VARIPULSE™ Bi-Directional CatheterQZI	Biosense Webster Inc	Cardiac Ablation Catheter (Pulsed Field/PFA)	418	41
FARAWAVE™ NAVQZI	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter (Pulsed Field/PFA)	386	40
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	335	3
TactiFlex™ Sensor Enabled™OAE	ABBOTT (ST. JUDE MEDICAL)	Cardiac Ablation Catheter for Atrial Fibrillation	313	6
Blazer® IILPB	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter (Percutaneous)	299	0
ThermoCool SmartTouchLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	296	2
TactiCath™OAE	ABBOTT (ST. JUDE MEDICAL)	Cardiac Ablation Catheter for Atrial Fibrillation	284	1
IntellaNav MiFi™ Open-IrrigatedOAD	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter for Atrial Flutter	275	1
QDOT MICROOAE	Biosense Webster Inc	Cardiac Ablation Catheter for Atrial Fibrillation	267	12
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	264	2

1–25 of 200 devices

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Post-market surveillance: a practical guide

Where MAUDE fits in the wider regulatory picture and the data sources teams rely on.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.