📊 Evidence-Based Reference
Peel-Away Introducer Set
Quinton
Summary: The peel-away introducer set by Quinton is a medical device used for catheter placement. Key evidence highlights its utility in minimally invasive procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K844693 ↗
Decision Date ?
March 6, 1985
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The peel-away introducer set was cleared by the FDA via the 510(k) pathway on March 6, 1985. It is manufactured by Quinton and classified as a Class 2 device.
What It Is
The peel-away introducer set is designed to facilitate the insertion of catheters into the body. It allows for the safe and efficient placement of catheters by providing a sheath that can be peeled away once the catheter is in place.
FDA-Cleared Indications
- Facilitation of percutaneous catheter insertion and placement.
- Use as an introducer sheath that can be peeled away after catheter placement.
Clinical Applications
- Percutaneous placement of catheters requiring an introducer sheath.
- Central venous catheter placement.
- Placement of catheters during minimally invasive vascular procedures.
Reported off-label uses
- Use during selected interventional radiology procedures to place embolization or drainage catheters when the specific catheter-and-sheath combination is not labeled for that application.
- Use for selected urologic catheter-placement procedures, including ureteral access, when appropriate for the anatomy and compatible with the catheter.
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 four studies ranging from 1987 to 2013, covering various applications of the peel-away introducer set. These studies include case series and other observational designs.
Reported Outcomes
Published studies report the peel-away introducer set as effective in facilitating catheter placement with minimal trauma. It has been shown to be useful in both antegrade and retrograde procedures, enhancing procedural efficiency.
Safety Profile
Reported complications include minimal trauma during insertion and potential for dislodgement of stents. Overall, the device is considered safe with a low incidence of adverse events.
Evidence Limitations
The evidence is limited by the small number of studies and lack of randomized controlled trials. Further research is needed to explore long-term outcomes and compare efficacy with alternative devices.
Practical Considerations
- Select the sheath inner diameter and length to match the catheter or device being placed; the sheath must be large enough to accommodate the device without excessive resistance.
- Use sterile technique and fluoroscopic, ultrasound, or other appropriate imaging guidance according to the procedure.
- The sheath is intended for temporary use and is peeled apart after the catheter is positioned; it is not generally left implanted.
- Confirm compatibility with the catheter, guidewire, dilator, and access site before use. Do not force devices through the sheath.
- MRI safety depends on the specific materials and model. The device should be treated as having unknown MRI status unless current manufacturer labeling confirms that it is MR Safe or MR Conditional.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for peel-away introducer set?
The device is indicated for catheter placement in procedures such as central venous access and ureteral interventions.
What outcomes have been reported in clinical studies?
Studies report effective catheter placement with minimal trauma and enhanced procedural efficiency.
What complications have been reported?
Safety data indicate minimal trauma during insertion and potential for stent dislodgement as complications.
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.