IntellaNav Open-Irrigated Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Cardiac Ablation Catheter for Atrial Flutter · First cleared Jul 2016 · 3 device variants grouped
Total Reports
518
Reports (30d)
1
Active Signals
0
Open Recalls
4
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.
Evidence
Related research
Citations indexed from PubMed.
Keep exploring
Related devices in Ablation
ThermoCool SmartTouch SF
Biosense Webster Inc · 5,902 reports
FARAWAVE
BOSTON SCIENTIFIC CORPORATION · 5,084 reports
TactiCath
ABBOTT (ST. JUDE MEDICAL) · 2,367 reports
PulseSelect
MEDTRONIC, INC. · 2,164 reports
Arctic Front Advance Pro
MEDTRONIC, INC. · 1,733 reports
QDOT MICRO
Biosense Webster Inc · 1,297 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 AccessUnderstanding this data