Prostar Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Vascular Hemostasis/Closure Device · First cleared May 2019
Total Reports
375
Reports (30d)
0
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Frayed Suture During Aortic Valve Procedure
pre close, using pre, valve, aortic, prostyle
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Keep exploring
Related devices in Coronary
Perclose ProGlide
ABBOTT VASCULAR INC. · 24,591 reports
Perclose ProStyle
ABBOTT VASCULAR INC. · 19,487 reports
PERCLOSE
ABBOTT VASCULAR INC. · 10,006 reports
Angio-Seal
TERUMO MEDICAL CORPORATION · 6,574 reports
SYNERGY
BOSTON SCIENTIFIC CORPORATION · 6,056 reports
Resolute Onyx
MEDTRONIC, INC. · 4,478 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. 1 active signal detected right now.
Get Early AccessUnderstanding this data