Inquiry Adverse Events: FDA MAUDE Data
IRVINE BIOMEDICAL, INC. · Catheter, Electrode Recording (EP Diagnostic) · First cleared Jul 1995 · 122 device variants grouped
Total Reports
161
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Packaging Defect Causing Catheter Breakage
achieve, replacement, material, replaced procedure, packaging
2
reports
Cardiac Tamponade from Catheter Kinking
pericardial effusion, tamponade, effusion, pericardial, pericardiocentesis
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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