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percutaneous sheath introducer kit
Arrow Intl.
Summary: The percutaneous sheath introducer kit by Arrow Intl. is used for vascular access. Key evidence highlights modified techniques reducing complications like kinking.
FDA Clearance Information
Pathway
510K
Number
K780532 ↗
Decision Date
April 21, 1978
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The percutaneous sheath introducer kit was cleared by the FDA via the 510(k) pathway on April 21, 1978. It is manufactured by Arrow Intl. and classified as a Class 2 device.
What It Is
The percutaneous sheath introducer kit is a medical device used to facilitate vascular access, typically in central veins. It is designed for percutaneous insertion, often used in procedures requiring catheter placement.
Clinical Applications
Commonly used in scenarios requiring reliable venous access, such as in pediatric patients for Hickman catheter placement or in procedures involving gastrostomy and jejunostomy.
Evidence Summary
The literature includes four studies ranging from 1989 to 2006, encompassing various study types. These studies explore modified techniques and their impact on procedural outcomes and safety.
Reported Outcomes
Published studies report that modified techniques using the percutaneous sheath introducer kit can reduce procedure time and complication rates, such as kinking and damage to the sheath. Serum CRP levels were also lower in modified groups.
Safety Profile
Reported complications include kinking and small damage to the sheath introducer, with higher rates in standard techniques compared to modified approaches. These findings suggest improved safety with technique modifications.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to validate findings across diverse patient populations and clinical settings.
Frequently Asked Questions
What are the clinical indications for the percutaneous sheath introducer kit?
The device is indicated for use in procedures requiring vascular access, such as catheter placement in central veins.
What outcomes have been reported in clinical studies?
Studies report reduced procedure time and complication rates with modified techniques, including lower serum CRP levels.
What complications have been reported?
Safety data indicate complications such as kinking and sheath damage, with higher rates in standard techniques compared to modified ones.
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.