đź“Š Evidence-Based Reference
percutaneous introducer
Medamicus
Summary: The percutaneous introducer by Medamicus is a device used for vascular access, primarily in catheterization procedures. Key evidence highlights rare but serious complications such as cerebral air embolism.
FDA Clearance Information
Pathway
510K
Number
K893658 ↗
Decision Date
August 3, 1989
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Medamicus percutaneous introducer was cleared by the FDA via the 510(k) pathway on August 3, 1989. It is classified as a Class 2 medical device.
What It Is
The percutaneous introducer is a medical device designed to facilitate the insertion of catheters into the vascular system. It is commonly used in procedures requiring vascular access, such as catheterization for hemodynamic monitoring.
Clinical Applications
This device is typically used in clinical scenarios requiring central venous access, such as the placement of pulmonary artery catheters or during percutaneous endoscopic gastrostomy procedures.
Evidence Summary
The literature includes 15 studies, ranging from case reports to randomized controlled trials, published between 2010 and 2024. These studies explore various clinical outcomes and complications associated with the device.
Reported Outcomes
Published studies report that the percutaneous introducer is effective in facilitating catheter placement for vascular access. However, complications such as catheter entrapment and misplacement have been documented.
Safety Profile
Reported complications include cerebral air embolism following sheath removal and catheter entrapment. These events, while rare, can lead to serious clinical consequences.
Evidence Limitations
The evidence is limited by the small number of randomized controlled trials and the predominance of case reports. Further research is needed to better understand the long-term safety and efficacy of the device.
Frequently Asked Questions
What are the clinical indications for the percutaneous introducer?
The device is indicated for use in procedures requiring vascular access, such as catheterization for hemodynamic monitoring and percutaneous endoscopic gastrostomy.
What outcomes have been reported in clinical studies?
Studies have reported effective catheter placement but also highlighted complications such as catheter entrapment and misplacement.
What complications have been reported?
Safety data from evidence indicate complications such as cerebral air embolism and catheter entrapment, which can have serious clinical implications.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.