Perclose ProGlide Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Vascular Hemostasis/Closure Device · First cleared Oct 2009 · 2 device variants grouped
Total Reports
24,635
Reports (30d)
9
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Suture Break During Arteriotomy Closure
proglide device, provided arteriotomy, arteriotomy closure, percutaneous, sheath reportedly
37
reports
Suture Break During Pre-Close Technique
ablation, pre placed, prostyle, prostyle device, femoral vein
9
reports
Plunger Failure in Pre-Close Technique
pre close, using pre, pre placed, close technique, prostyle
5
reports
Device Breakage Before Use
prostyle, using prostyle, body, prostyle device, procedure reportedly
3
reports
Incomplete Retraction of Closure Device
provided arteriotomy, using pre, arteriotomy closure, prostyle devices, prostyle
2
reports
Suture Break During Access Site Closure
provided arteriotomy, arteriotomy closure, sutures, pre placed, prostyle
1
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
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
Ambulatory pulmonary vein isolation workflow using the Perclose ProglideTM suture-mediated vascular closure device: the PRO-PVI study
Davide Fabbricatore, et al. · EP Europace · 2023
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
Citations indexed from PubMed.
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