IntellaNav MiFi Open-Irrigated Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Cardiac Ablation Catheter for Atrial Flutter · First cleared Aug 2017 · 3 device variants grouped
Total Reports
402
Reports (30d)
0
Active Signals
0
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
Inconsistent Irrigation Flow During Ablation
observed, thermocool, ablation procedure, patients, study
1
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
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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