📊 Evidence-Based Reference
Cordis Catheter Sheath Introducer
Summary: The Cordis Catheter Sheath Introducer is a device used for vascular access, primarily in central venous catheterization. Key evidence highlights its utility in complex vascular procedures with a focus on minimizing complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K932733 ↗
Decision Date ?
August 26, 1993
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Cordis Catheter Sheath Introducer was cleared via the FDA 510(k) pathway on August 26, 1993. It is manufactured by Cordis and classified as a Class 2 device.
What It Is
The Cordis Catheter Sheath Introducer is a medical device designed to facilitate the insertion of catheters into the vascular system. It is equipped with a hemostatic valve to prevent blood loss and is commonly used in central venous catheterization.
FDA-Cleared Indications
- Introduction of catheters into the vascular system.
- Maintenance of vascular access during catheter-based procedures.
- Use when a hemostatic valve is needed to reduce blood loss during catheter insertion and exchange.
Clinical Applications
- Establishing access for central venous catheterization.
- Supporting hemodynamic monitoring through vascular catheters.
- Providing access for infusion of multiple solutions or medications.
- Maintaining catheter access during diagnostic or interventional vascular procedures.
Reported off-label uses
- Providing arterial access for embolization and other endovascular interventions when the selected sheath size and configuration are appropriate.
- Maintaining access during neurointerventional procedures such as aneurysm coiling or AVM embolization when used according to institutional practice.
- Providing access during transjugular procedures, including portal venous interventions, when the device is compatible with the planned technique.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes a mix of study types, such as RCTs and case series, with a total of 5 studies spanning from 1979 to 2022. These studies explore various applications and outcomes of the device.
Reported Outcomes
Published studies report successful use of the Cordis Catheter Sheath Introducer in complex vascular procedures, including coronary angioplasty and central venous access. The device has been shown to improve hemostasis and facilitate efficient catheterization in critically ill patients.
Safety Profile
Reported complications include vascular spasm and pain when larger introducer sheaths are used, particularly in distal transradial artery procedures. However, the use of slender techniques may mitigate these issues.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in study design. Further research is needed to explore long-term outcomes and to validate findings across diverse patient populations.
Practical Considerations
- Available sizes, lengths, dilators, and catheter compatibility should be confirmed for the planned procedure; the appropriate size depends on the catheter or devices that must pass through it.
- The access site may be central venous, peripheral venous, or arterial depending on the procedure and the specific labeled configuration. Use sterile technique and imaging guidance when clinically appropriate.
- The hemostatic valve reduces blood loss but does not eliminate bleeding, air entry, thrombosis, infection, vascular injury, or hematoma risk.
- MRI safety depends on the exact model and whether the sheath remains in place; confirm the product-specific MRI labeling before scanning.
- This is generally a temporary access device rather than a long-term implant. Avoid use when the access route is unsuitable or when the patient has a contraindication to the planned vascular procedure.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Cordis Catheter Sheath Introducer?
The device is indicated for use in central venous catheterization and other procedures requiring vascular access.
What outcomes have been reported in clinical studies?
Studies have reported successful catheterization and improved hemostasis, particularly in complex vascular procedures.
What complications have been reported?
Safety data indicate potential complications such as vascular spasm and pain, especially with larger sheath sizes.
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.