StarClose SE Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Vascular Hemostasis/Closure Device · First cleared Apr 2018 · 2 device variants grouped
Total Reports
983
Reports (30d)
5
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Clip Visibility After Device Removal
provided arteriotomy, arteriotomy closure, delay procedure, artery using, significant delay
19
reports
Access-Site Complications with Device Use
perclose, venous, complications, proglide, prostyle
1
reports
Frayed Suture During Aortic Valve Procedure
pre close, using pre, valve, aortic, prostyle
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
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