IntellaNav Open-Irrigated Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Cardiac Ablation Catheter for Atrial Flutter · First cleared Feb 2016
Total Reports
511
Reports (30d)
0
Active Signals
1
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
Electrode Noise During Ablation Procedure
observed, left, ablation procedure, completed, mapping
5
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Nov 28, 2018 · Open, Classified
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.
Nov 28, 2018 · Open, Classified
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.
Nov 28, 2018 · Open, Classified
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.
Jun 20, 2018 · Open, Classified
Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
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