📊 Evidence-Based Reference
Subclavian Introducer Set
Infusaid
Summary: The subclavian introducer set by Infusaid is a medical device used for vascular access, primarily in central venous catheterization. Key evidence highlights its efficacy in facilitating catheter placement with minimal complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K902251 ↗
Decision Date ?
July 31, 1990
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The subclavian introducer set was cleared by the FDA through the 510(k) pathway on July 31, 1990. It is manufactured by Infusaid and classified as a Class 2 device.
What It Is
The subclavian introducer set is designed to facilitate the insertion of catheters into the subclavian vein. It is used in clinical settings for procedures requiring central venous access, such as the placement of pacemaker leads or long-term central venous catheters.
FDA-Cleared Indications
- Facilitation of catheter placement through the subclavian vein for central venous access.
- Access for placement of pacemaker or defibrillator leads.
- Access for catheter placement during hemodynamic studies.
- Access for ventriculovenous shunt procedures.
Clinical Applications
- Obtaining subclavian venous access for central venous catheter placement.
- Facilitating placement of pacemaker leads.
- Facilitating placement of defibrillator leads.
- Providing access for selected hemodynamic studies.
- Providing access for ventriculovenous shunt procedures.
Evidence Summary
The literature includes six studies ranging from 1983 to 1999, encompassing various study types such as RCTs and case series. These studies evaluate the device's efficacy and safety in different clinical applications.
Reported Outcomes
Published studies report high success rates in lead placement using the subclavian introducer set, with a noted overall success rate of 49 cases in one study. The device is associated with shorter lead placement times and fewer contrast injections when using the medial approach.
Safety Profile
Reported complications include a low incidence of major complications, with one study specifically noting no major complications during the use of the subclavian introducer set for lead placement.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to evaluate long-term outcomes and to compare the efficacy of the subclavian introducer set with alternative devices.
Practical Considerations
- The set is intended for venous access through the subclavian region; the exact introducer, dilator, sheath and catheter dimensions should be matched to the planned procedure.
- Use requires sterile technique and imaging or physiologic guidance appropriate to the procedure. Operators should confirm venous entry and catheter position before use.
- Potential complications of subclavian venous access include bleeding, hematoma, infection, arterial puncture, pneumothorax, hemothorax, thrombosis and air embolism.
- MRI safety depends on the specific components and whether any device remains in the patient. Do not assume MRI compatibility from the introducer-set name; check the current product labeling.
- Contraindications and precautions include infection at the access site, uncorrected significant bleeding risk, thrombosis or occlusion of the intended vein, and inability to safely identify or access the vessel.
Frequently Asked Questions
What are the clinical indications for subclavian introducer set?
The subclavian introducer set is indicated for procedures requiring central venous access, such as the placement of pacemaker leads and long-term central venous catheters.
What outcomes have been reported in clinical studies?
Clinical studies have reported high success rates in catheter and lead placement, with shorter procedure times and fewer complications using the medial approach.
What complications have been reported?
Safety data from studies indicate a low incidence of major complications, with some studies reporting no major complications during the use of the device.
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.