PERCLOSE Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Vascular Hemostasis/Closure Device · First cleared Oct 2009
Total Reports
10,082
Reports (30d)
21
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Suture Break During Knot Advancement
provided arteriotomy, arteriotomy closure, prostyle, using prostyle, prostyle device
36
reports
Plunger Failure in Pre-Close Technique
pre close, using pre, pre placed, close technique, prostyle
11
reports
Suture Break During Pre-Close Technique
ablation, pre placed, prostyle, prostyle device, femoral vein
9
reports
Suture Break During Access Site Closure
provided arteriotomy, arteriotomy closure, sutures, pre placed, prostyle
9
reports
Device Breakage Before Use
prostyle, using prostyle, body, prostyle device, procedure reportedly
9
reports
Incomplete Retraction of Closure Device
provided arteriotomy, using pre, arteriotomy closure, prostyle devices, prostyle
8
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
The Side‐Arm Technique on Perclose (STOP) Hemostasis Method to Prevent Bleeding With Indwelling Large Bore Catheters; Concept and Early Results
Stéphane Rinfret, et al. · Catheterization and Cardiovascular Interventions · 2026
A novel technique for postclosure of large‐bore sheaths using two Perclose devices
Charles H. Choi, et al. · Catheterization and Cardiovascular Interventions · 2020
<scp>Propensity‐matched</scp> comparison of <scp>large‐bore</scp> access closure in transcatheter aortic valve replacement using <scp>MANTA</scp> versus Perclose: A <scp>real‐world</scp> experience
Giorgio A. Medranda, et al. · Catheterization and Cardiovascular Interventions · 2021
Comparative analysis of vascular closure devices for neuroendovascular procedures using Perclose versus Angioseal
Takehiro Uno, et al. · Heliyon · 2024
Citations indexed from PubMed.
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