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INTELLANAV STABLEPOINT Adverse Events: FDA MAUDE Data

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

Total Reports

441

Reports (30d)

3

Active Signals

1

Open Recalls

7

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Pericardial Effusion Post-Ablation

pericardial effusion, pericardial, effusion, qdot, pericardiocentesis

4

reports

2

Communication Failure During Procedure

tactisys, completed adverse, procedural delay, tactiflex, ensite

1

reports

3

Electrode Noise During Ablation Procedure

observed, left, ablation procedure, completed, mapping

1

reports

4

Irrigation Failure with Micro Catheter

micro catheter, qdot micro, flow, irrigation issue, qdot

1

reports

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

Detection

Active safety signals

Disproportionate reportinghigh

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.

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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.

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.