Perclose ProGlide Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Vascular Hemostasis/Closure Device · First cleared Oct 2009 · 2 device variants grouped
Total Reports
24,665
Reports (30d)
13
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Suture Break Delays Hemostasis
proglide device, provided arteriotomy, arteriotomy closure, significant delay, delay
45
reports
Device Stuck in Access Site
closure right, pre placed, close technique, prostyle, prostyle device
4
reports
Foot Failure During Pre-Close
pre close, pre placed, close technique, prostyle, prostyle device
4
reports
Suture Break During Arteriotomy Closure
provided arteriotomy, arteriotomy closure, prostyle, using prostyle, prostyle device
2
reports
Suture Stuck During Pre-Close
pre close, using pre, pre placed, prostyle, prostyle device
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Perclose Proglide Embolization As a Complication: Case Report and Review of Literature
Larab L. Giniyani, et al. · Future Cardiology · 2021
Endovascular Perclose ProGlide complication puncture site, treated successful by cutting balloon dilatation: A case report and literature review
Yulong Huang, et al. · Science Progress · 2024
Dual ProGlide vs ProGlide and Angio-Seal for Femoral Access Hemostasis After Transcatheter Aortic Valve Replacement: A Randomised Comparative Trial
Chih‐Fan Yeh, et al. · Canadian Journal of Cardiology · 2024
Femoral vessel cannulation strategies in minimally invasive cardiac surgery: single Perclose ProGlide versus open cut-down
Majd Ismail, et al. · European Journal of Cardio-Thoracic Surgery · 2025
Efficacy and safety of post-closure technique using Perclose ProGlide/ProStyle device for large-bore mechanical circulatory support access sites
Takashi Unoki, et al. · Cardiovascular revascularization medicine · 2023
Citations indexed from PubMed.
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