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catheter introducer sheath
Applied Vascular Devices
Summary: The catheter introducer sheath by Applied Vascular Devices is used for vascular access in various clinical procedures. Key evidence highlights its role in reducing surgical trauma and potential complications like vein perforation.
FDA Clearance Information
Pathway
510K
Number
K890766 ↗
Decision Date
September 18, 1989
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The catheter introducer sheath was cleared by the FDA through the 510(k) pathway on September 18, 1989. It is manufactured by Applied Vascular Devices and classified as a Class 2 medical device.
What It Is
The catheter introducer sheath is a medical device designed to facilitate the insertion of catheters into blood vessels. It is commonly used in procedures requiring vascular access, such as the placement of pulmonary artery catheters or during endoscopic surgeries.
Clinical Applications
This device is frequently used in clinical scenarios requiring reliable vascular access, such as measuring hepatic venous pressure gradients or performing transjugular liver biopsies. It is also utilized in pediatric endoscopic skull base surgeries to minimize nasal trauma.
Evidence Summary
The available literature includes 14 studies, comprising randomized controlled trials, prospective and retrospective studies, and case reports. The studies span from 1989 to 2020, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the catheter introducer sheath is effective in facilitating vascular access with minimal trauma. It has been shown to reduce nasal injury during pediatric surgeries and is essential in procedures like hepatic venous pressure gradient measurement.
Safety Profile
Reported complications include vein perforation, as noted in a case report where the right innominate vein was perforated during catheter placement. Other studies highlight the importance of careful insertion to avoid such adverse events.
Evidence Limitations
The evidence is limited by the small sample sizes in some studies and the lack of long-term follow-up data. Further research is needed to explore the device's efficacy in diverse patient populations and to better understand its safety profile.
Frequently Asked Questions
What are the clinical indications for catheter introducer sheath?
The device is indicated for procedures requiring vascular access, such as catheter placements and certain endoscopic surgeries.
What outcomes have been reported in clinical studies?
Studies report effective vascular access with reduced trauma, particularly in pediatric surgeries and hepatic procedures.
What complications have been reported?
Safety data indicate potential complications like vein perforation, emphasizing the need for careful insertion techniques.
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.