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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 ?
510(k)
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.
FDA-Cleared Indications
- Percutaneous introduction of catheters or other intravascular devices into a blood vessel.
- Establishment of vascular access for procedures requiring catheter placement.
- Use as an introducer sheath and related access components in accordance with the specific cleared product labeling.
Clinical Applications
- Obtaining percutaneous venous access for catheter placement.
- Providing an access route for central venous catheter procedures.
- Supporting vascular access during procedures in which a catheter must be introduced through a sheath.
Reported off-label uses
- Access for interventional radiology embolization procedures, including arterial embolization, when the sheath size and configuration are appropriate.
- Access for complex venous interventions, such as portal venous or transjugular procedures, when selected and used by a qualified clinician.
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 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.
Practical Considerations
- Select the sheath diameter and length based on the target vessel, catheter or device size, and procedural access route.
- Use imaging guidance and sterile technique appropriate to the access site; ultrasound may assist venous puncture and fluoroscopy may guide catheter placement.
- Confirm compatibility among the sheath, dilator, guidewire, and catheter before use. Inspect components for damage and follow the product instructions for use.
- A sheath introducer is generally a temporary procedural access device rather than a long-term implant. The access site should be monitored for bleeding, hematoma, infection, thrombosis, vessel injury, or air embolism.
- MRI safety depends on the specific kit components and whether any part remains in the patient. Check the current manufacturer labeling before MRI; do not assume that an unspecified kit is MR safe.
Procedures that use this device
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.