Electrophysiology: Ablation Adverse Event Data

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

Total Reports

30,736

Devices Tracked

200

Reports (30d)

610

Active Signals

Monthly Report Volume

Event Type Breakdown

Devices in Ablation

Device	Manufacturer	Type	Total Reports	Last 30d
FARAWAVE™QZI	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter (Pulsed Field/PFA)	4,167	139
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	3,931	26
PulseSelect™QZI	MEDTRONIC, INC.	Cardiac Ablation Catheter (Pulsed Field/PFA)	2,157	102
Arctic Front Advance Pro™OAE	MEDTRONIC, INC.	Cardiac Ablation Catheter for Atrial Fibrillation	1,719	0
TactiCath™OAE	ABBOTT (ST. JUDE MEDICAL)	Cardiac Ablation Catheter for Atrial Fibrillation	1,049	1
QDOT MICROOAD	Biosense Webster Inc	Cardiac Ablation Catheter for Atrial Flutter	1,015	12
ThermoCool SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	1,010	0
Sphere-9™ CatheterQZI	MEDTRONIC, INC.	Cardiac Ablation Catheter (Pulsed Field/PFA)	761	56
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	713	12
ThermoCool SmartTouchLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	637	17
Arctic Front®OAE	MEDTRONIC, INC.	Cardiac Ablation Catheter for Atrial Fibrillation	568	11
VARIPULSE™ Bi-Directional CatheterQZI	Biosense Webster Inc	Cardiac Ablation Catheter (Pulsed Field/PFA)	553	33
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	547	0
IntellaNav™ Open-IrrigatedOAD	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter for Atrial Flutter	512	1
Arctic Front Advance™OAE	MEDTRONIC, INC.	Cardiac Ablation Catheter for Atrial Fibrillation	510	0
FARAWAVE™ NAVQZI	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter (Pulsed Field/PFA)	505	26
INTELLANAV STABLEPOINT™OAE	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter for Atrial Fibrillation	452	2
THERMOCOOL SMARTTOUCH SFLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	343	2
TactiFlex™ Sensor Enabled™OAE	ABBOTT (ST. JUDE MEDICAL)	Cardiac Ablation Catheter for Atrial Fibrillation	334	4
FARAWAVE™QZI	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter (Pulsed Field/PFA)	326	6
Blazer® IILPB	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter (Percutaneous)	313	0
QDOT MICROOAE	Biosense Webster Inc	Cardiac Ablation Catheter for Atrial Fibrillation	304	20
ThermoCool SmartTouchLPB	Biosense Webster Inc	Cardiac Ablation Catheter (Percutaneous)	303	3
TactiCath™OAE	ABBOTT (ST. JUDE MEDICAL)	Cardiac Ablation Catheter for Atrial Fibrillation	293	6
IntellaNav MiFi™ Open-IrrigatedOAD	BOSTON SCIENTIFIC CORPORATION	Cardiac Ablation Catheter for Atrial Flutter	276	0

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.