Perclose ProStyle Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Vascular Hemostasis/Closure Device · First cleared Aug 2022
Total Reports
19,648
Reports (30d)
53
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Suture Break During Arteriotomy Closure
provided arteriotomy, arteriotomy closure, prostyle, using prostyle, prostyle device
34
reports
Device Stuck in Access Site
closure right, pre placed, close technique, prostyle, prostyle device
32
reports
Suture Stuck During Pre-Close
pre close, using pre, pre placed, prostyle, prostyle device
22
reports
Foot Failure During Pre-Close
pre close, pre placed, close technique, prostyle, prostyle device
17
reports
Sealant Failure During Deployment
control vascular, mynx control, balloon, verified, sealant
6
reports
Locator Kink Prevents Deployment
loss, blood loss, angio, received following, angio seal
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Keep exploring
Related devices in Coronary
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