📊 Evidence-Based Reference
Percutaneous Introducer Kit
Cormed, Inc., Sub. C.R.Bard
Summary: The percutaneous introducer kit by Cormed, Inc. is a device used primarily for vascular access and embolization procedures. Key evidence highlights its utility in reducing infection rates during percutaneous endoscopic gastrostomy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K860432 ↗
Decision Date ?
March 31, 1986
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The percutaneous introducer kit was cleared by the FDA via the 510(k) pathway on March 31, 1986. It is manufactured by Cormed, Inc., a subsidiary of C.R. Bard, and is classified as a Class 2 medical device.
What It Is
The percutaneous introducer kit is designed to facilitate the insertion of catheters or other devices into the vascular system. It is commonly used in procedures requiring vascular access, such as embolization or gastrostomy.
FDA-Cleared Indications
- Percutaneous introduction of catheters or other instruments into the vascular system.
- Facilitation of vascular access for diagnostic or therapeutic procedures.
- Use with compatible catheters or devices according to the kit labeling and physician instructions.
Clinical Applications
- Obtaining percutaneous vascular access for catheter-based procedures.
- Providing access for embolization procedures.
- Facilitating placement of access devices used during percutaneous endoscopic gastrostomy when specified by the product labeling.
- Supporting catheter introduction into the vascular system for interventional procedures.
Reported off-label uses
- Access for selected nonvascular percutaneous procedures when the kit components are appropriate and the treating physician determines that use is suitable.
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 13 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series, spanning from 2012 to 2023. These studies evaluate the device's efficacy and safety in various clinical applications.
Reported Outcomes
Published studies report that the percutaneous introducer kit is effective in reducing peristomal infection rates during percutaneous endoscopic gastrostomy. The device has been shown to facilitate safe and efficient vascular access, with some studies highlighting its utility in patients with upper digestive tract stenosis.
Safety Profile
Reported complications include peristomal infections, which have been reduced with the use of systemic prophylactic antibiotics. The device's design and technique have been associated with lower infection rates compared to traditional methods.
Evidence Limitations
While the studies provide valuable insights, there are limitations such as small sample sizes and the need for more randomized controlled trials to further validate findings. Future research could focus on long-term outcomes and comparisons with alternative devices.
Practical Considerations
- Available sizes, dilator dimensions, guidewire compatibility, and sheath length depend on the specific kit configuration and should be confirmed in the product labeling.
- Use only with compatible catheters, guidewires, dilators, and other components; inspect packaging and components for damage before use.
- Insertion is generally performed with sterile technique and imaging guidance, such as ultrasound and fluoroscopy, depending on the access site and procedure.
- MRI safety cannot be determined from the FDA record alone. Confirm the exact kit components and their current MR labeling before an MRI examination.
- Potential complications include bleeding, hematoma, infection, vessel injury, thrombosis, air embolism, and damage to the access tract; patient-specific contraindications and precautions should be assessed before use.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for percutaneous introducer kit?
The device is indicated for use in procedures requiring vascular access, such as percutaneous endoscopic gastrostomy and embolization.
What outcomes have been reported in clinical studies?
Studies have reported reduced infection rates and effective vascular access facilitation, particularly in gastrostomy procedures.
What complications have been reported?
Safety data indicate that complications such as peristomal infections can occur, but these are mitigated with prophylactic antibiotics.
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.