📊 Evidence-Based Reference
Triple Lumen Right Atrial Catheter
Quinton
Summary: The triple lumen right atrial catheter by Quinton is used for hemodynamic monitoring and long-term venous access. Key evidence highlights its use in pediatric cardiac surgery and associated risks of thrombus formation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K852815 ↗
Decision Date ?
August 26, 1985
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The triple lumen right atrial catheter was cleared by the FDA via the 510k pathway on August 26, 1985. It is manufactured by Quinton and classified as a Class 2 device.
What It Is
The triple lumen right atrial catheter is a medical device designed for insertion into the right atrium of the heart. It is used primarily for hemodynamic monitoring and long-term venous access in clinical settings.
FDA-Cleared Indications
- Percutaneous catheterization of a central vein for access to the right atrium.
- Hemodynamic monitoring in patients requiring central venous pressure or other right-sided cardiac pressure measurements.
- Administration of intravenous fluids, medications, nutrition, or blood products when central venous access is needed.
Clinical Applications
- Central venous access during selected pediatric cardiac surgery.
- Hemodynamic monitoring through a right atrial catheter.
- Long-term administration of intravenous fluids or medications.
- Administration of parenteral nutrition through central venous access.
- Repeated central venous blood sampling when clinically indicated.
Reported off-label uses
- Use as temporary central access for prolonged intensive-care treatment when the catheter configuration is clinically appropriate.
- Use for selected infusion protocols requiring multiple independent central lumens, when consistent with institutional policy and the device labeling.
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 13 studies, comprising various study types such as RCTs, prospective, and retrospective studies, conducted between 2004 and 2020. These studies explore the device's efficacy and safety in clinical practice.
Reported Outcomes
Published studies report that the triple lumen right atrial catheter is effective for hemodynamic monitoring in pediatric cardiac surgery. It is also noted for its utility in providing long-term venous access, although specific efficacy metrics are not detailed in the available summaries.
Safety Profile
Reported complications include catheter-associated bloodstream infections and right atrial thrombus formation. These adverse events highlight the need for careful monitoring and management when using the device.
Evidence Limitations
The evidence base lacks comprehensive data on long-term outcomes and specific efficacy metrics. Further research is needed to better understand the risk factors for complications and to optimize device use in various clinical scenarios.
Practical Considerations
- The device has three separate lumens, but exact catheter length, French size, lumen volumes, and flow characteristics should be confirmed in the original labeling or product documentation.
- Placement requires sterile technique and imaging or physiologic confirmation of the catheter tip; possible access sites include the internal jugular, subclavian, or femoral vein depending on the clinical situation.
- The catheter should be checked for compatibility with the intended infusates, pressure limits, injection requirements, and required flushing or locking solution before use.
- MRI safety is not established from the FDA record provided. Confirm the specific catheter model and its current MRI labeling before MRI examination.
- Important risks include infection, bleeding, venous or right atrial perforation, arrhythmia, air embolism, malposition, catheter occlusion, and thrombus formation. Placement may be inappropriate in patients with infection at the access site, uncorrected severe bleeding risk, or anatomy that prevents safe access.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for triple lumen right atrial catheter?
The device is indicated for hemodynamic monitoring and long-term venous access, particularly in pediatric cardiac surgery and patients requiring chemotherapy or parenteral nutrition.
What outcomes have been reported in clinical studies?
Studies report effective hemodynamic monitoring and long-term venous access, though specific efficacy metrics are not detailed in the summaries.
What complications have been reported?
Safety data indicate risks of catheter-associated bloodstream infections and right atrial thrombus formation.
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.