Login Get Early Access

Back to Electrophysiology: Ablation

INTELLANAV STABLEPOINT Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · Cardiac Ablation Catheter for Atrial Fibrillation · First cleared Feb 2016

Total Reports

447

Reports (30d)

2

Active Signals

0

Open Recalls

7

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Cardiac Tamponade from Micro Catheter Use

micro catheter, micro, qdot micro, used, qdot

6

reports

2

Inconsistent Irrigation Flow with Overheating

observed, temperature, high, completed, used

4

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Regulatory

FDA recalls for this device

Class I

Oct 10, 2024 · Open, Classified

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Class I

Oct 10, 2024 · Open, Classified

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Class I

Oct 10, 2024 · Open, Classified

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Class I

Oct 10, 2024 · Open, Classified

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Class I

Oct 10, 2024 · Open, Classified

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Class I

Oct 10, 2024 · Open, Classified

Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.

Evidence

Related research

Characteristics and optimal ablation settings of a novel, contact‐force sensing and local impedance‐enabled catheter in an ex vivo perfused swine ventricle model

Kenta Tsutsui, et al. · Journal of Cardiovascular Electrophysiology · 2021

Prospective evaluation of local impedance drop to guide left atrial posterior wall ablation with high power

Francesco Solimene, et al. · Journal of Interventional Cardiac Electrophysiology · 2022

Local impedance measurements during contact force‐guided cavotricuspid isthmus ablation for predicting an effective radiofrequency ablation

Takehito Sasaki, et al. · Journal of Arrhythmia · 2022

Improved Ablation Efficiency in PVI Guided by Contact Force and Local Impedance: Chronic Canine Model

Sarah R. Gutbrod, et al. · Frontiers in Physiology · 2022

Citations indexed from PubMed.

Keep exploring

Related devices in Ablation

ThermoCool SmartTouch SF

Biosense Webster Inc · 5,860 reports

FARAWAVE

BOSTON SCIENTIFIC CORPORATION · 4,906 reports

PulseSelect

MEDTRONIC, INC. · 2,055 reports

Arctic Front Advance Pro

MEDTRONIC, INC. · 1,722 reports

TactiCath

ABBOTT (ST. JUDE MEDICAL) · 1,048 reports

Sphere-9 Catheter

MEDTRONIC, INC. · 1,011 reports

Want automated safety signal detection?

Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.

Get Early Access

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.

How a safety signal is detected

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

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.