📊 Evidence-Based Reference
Dual Lumen Catheter Model Dl-35-90
Summary: The dual lumen catheter model DL-35-90 by Endologix is primarily used for venous stenting. Key evidence highlights its efficacy in complex fluid drainage and challenges with malposition in neonates.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K991601 ↗
Decision Date ?
October 28, 1999
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The dual lumen catheter model DL-35-90 was cleared by the FDA via the 510(k) pathway on October 28, 1999. It is manufactured by Endologix and classified as a Class 2 device.
What It Is
The dual lumen catheter model DL-35-90 is designed for venous stenting, facilitating the drainage of complex fluid collections. It features a dual lumen design to enhance fluid evacuation and is intended for use in various clinical settings requiring venous access.
FDA-Cleared Indications
- Percutaneous catheter use as described under FDA product code DQY and 21 CFR 870.1250.
Clinical Applications
- Percutaneous catheter placement when clinically indicated by the treating physician.
- Use of the catheter's two lumens for separate infusion, drainage, monitoring, or access functions when consistent with the cleared labeling and instructions for use.
Reported off-label uses
- Use in complex fluid drainage procedures.
- Use for venous access during venovenous extracorporeal membrane oxygenation.
- Use during percutaneous translumbar inferior vena cava catheterization.
- Use in venous stenting procedures.
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 10 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series, published between 2014 and 2023. These studies explore the device's efficacy and safety in various clinical contexts.
Reported Outcomes
Published studies report that the dual lumen catheter is effective in enhancing fluid evacuation in complex drainage scenarios. It has been shown to improve hemodynamics in neonatal patients when correctly positioned. However, recirculation remains a challenge in ECMO applications.
Safety Profile
Reported complications include malposition in neonatal patients, which can affect hemodynamics, and potential recirculation issues during ECMO. These complications highlight the need for careful device placement and monitoring.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials and variability in study designs. Further research is needed to quantify recirculation rates and optimize catheter positioning techniques.
Practical Considerations
- Confirm the current manufacturer instructions for use, catheter dimensions, lumen configuration, pressure limits, and compatible guidewires or accessories before use.
- The model name suggests a 35 cm catheter with a 9 French size, but the exact dimensions should be verified in the original labeling rather than inferred from the model number.
- Placement should be performed with appropriate imaging guidance and sterile technique by clinicians trained in percutaneous catheter procedures.
- MRI safety and conditional-use information are not established by the supplied FDA record; verify the device's labeling before MRI.
- Potential complications include bleeding, infection, thrombosis, vessel injury, catheter malfunction, malposition, and damage during advancement or removal.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for dual lumen catheter model DL-35-90?
The dual lumen catheter is indicated for venous stenting and drainage of complex fluid collections, particularly in ECMO and inferior vena cava catheterization.
What outcomes have been reported in clinical studies?
Studies have reported effective fluid evacuation and improved hemodynamics in neonatal patients, though challenges with recirculation in ECMO persist.
What complications have been reported?
Safety data indicate complications such as malposition in neonates and recirculation issues during ECMO, necessitating careful monitoring and placement.
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.