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Guidewire Introducer Set
B. Braun Of America
Summary: The guidewire introducer set by B. Braun Of America is a medical device used primarily for vascular access. Key evidence highlights its role in endovascular procedures with a focus on safety and efficacy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K915421 ↗
Decision Date ?
February 27, 1992
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The guidewire introducer set was cleared by the FDA through the 510(k) pathway on February 27, 1992. It is manufactured by B. Braun Of America and classified as a Class 2 device under product code DYB.
What It Is
The guidewire introducer set is a medical device designed to facilitate the insertion of guidewires into the vascular system. It is used in various endovascular procedures to ensure accurate placement and access.
FDA-Cleared Indications
- Facilitate the introduction of guidewires into the vascular system during endovascular procedures.
- Provide vascular access for the placement and exchange of guidewires and compatible catheter systems.
Clinical Applications
- Obtaining vascular access before catheter-based embolization procedures.
- Supporting guidewire placement during endovascular aneurysm repair.
- Facilitating guidewire and catheter access during diagnostic angiography and other endovascular interventions.
Evidence Summary
The literature includes 11 studies ranging from 2008 to 2024, encompassing various study types such as RCTs, prospective, and retrospective analyses. These studies explore the device's application in endovascular procedures.
Reported Outcomes
Published studies report that the guidewire introducer set is effective in facilitating vascular access during complex endovascular procedures. It has been shown to improve procedural success rates and reduce the time required for device placement.
Safety Profile
Reported complications include minor vascular trauma and guidewire kinking, which are generally manageable with proper technique. No major adverse events have been consistently reported across studies.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish comprehensive safety profiles and to explore the device's efficacy in diverse patient populations.
Practical Considerations
- The introducer, dilator, and guidewire must be matched for size and compatibility with the intended catheter system and access vessel.
- Available sizes and lengths vary by product configuration; the specific device labeling should be checked before use.
- Insertion is typically performed under fluoroscopic or ultrasound guidance using sterile technique and local anesthesia, with or without conscious sedation.
- Potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, embolization, and damage to the guidewire or catheter.
- MRI safety depends on the exact components and whether any metallic or ferromagnetic parts remain in the patient; the product-specific labeling should be reviewed.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for guidewire introducer set?
The guidewire introducer set is indicated for use in procedures requiring vascular access, such as embolization and endovascular aneurysm repair.
What outcomes have been reported in clinical studies?
Studies report improved procedural success rates and reduced time for device placement when using the guidewire introducer set.
What complications have been reported?
Safety data indicate minor vascular trauma and guidewire kinking as potential complications, with no major adverse events consistently reported.
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.