QDOT MICRO Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Cardiac Ablation Catheter for Atrial Flutter
Total Reports
967
Reports (30d)
20
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Pericardial Effusion Post-Ablation
pericardial effusion, pericardial, effusion, qdot, pericardiocentesis
20
reports
Catheter Hole Causing Ablation Failure
mdr reportable, pebax, hole, medtech, qdot
11
reports
Irrigation Failure with Micro Catheter
micro catheter, qdot micro, flow, irrigation issue, qdot
7
reports
Detached Tip Not Contacting Patient
completed adverse, adverse consequences, notice, prior, consequences patient
1
reports
Electrode Noise During Ablation Procedure
observed, left, ablation procedure, completed, mapping
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
Regulatory
FDA recalls for this device
Sep 7, 2022 · Open, Classified
Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.
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