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Modification to Outback Catheter
Lumend
Summary: The modification to the Outback Catheter by Lumend is a device used in venous stenting procedures. It is FDA 510k cleared and primarily used for peripheral artery interventions. Two studies provide evidence on its clinical use.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K014117 ↗
Decision Date ?
January 11, 2002
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The modification to the Outback Catheter was cleared through the FDA 510k pathway on January 11, 2002. Manufactured by Lumend, it is classified as a Class 2 device under product code DQY.
What It Is
The modification to the Outback Catheter is a medical device designed for use in venous stenting procedures. It facilitates the placement of stents in peripheral arteries, particularly in challenging anatomical locations.
FDA-Cleared Indications
- Use as a percutaneous catheter as described in the FDA-cleared labeling.
- The FDA record identifies the device under product code DQY, Catheter, Percutaneous, 21 CFR 870.1250.
Clinical Applications
- Percutaneous catheter-based vascular procedures within the limits of the cleared labeling.
- Use with compatible endovascular equipment when specified by the device instructions for use.
Reported off-label uses
- Re-entry or crossing of difficult peripheral vascular occlusions has been reported for Outback-type catheter systems, but this should not be assumed to apply to this modified device without reviewing its labeling.
- Use during selected venous recanalization or venous-stenting procedures may occur in practice, but the specific indication should be confirmed from the device instructions for use.
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 two studies focusing on the device's use in peripheral arteries above and below the knee. These studies are registered on ClinicalTrials.gov, though specific details on outcomes and safety are not provided.
Reported Outcomes
Published studies report limited data on the efficacy of the modification to the Outback Catheter. The studies focus on its use in peripheral artery interventions, but specific outcomes have not been detailed in the provided evidence.
Safety Profile
Reported complications include limited safety data from the available studies. Specific adverse events or complications have not been detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data in the available studies. Further research is needed to establish comprehensive efficacy and safety profiles for the device.
Practical Considerations
- Confirm the exact catheter model, dimensions, guidewire requirements, and compatible sheath size in the current instructions for use.
- The available FDA summary does not specify MRI safety. Do not assume the device is MR Safe or MR Conditional without manufacturer documentation.
- Use requires fluoroscopic or other appropriate imaging guidance and trained endovascular personnel.
- Review contraindications, warnings, vessel-size limitations, and compatibility requirements before use.
- The catheter is a single-use endovascular device; it is not intended to remain implanted after the procedure.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for modification to Outback Catheter?
The device is indicated for use in venous stenting procedures, particularly in peripheral artery interventions above and below the knee.
What outcomes have been reported in clinical studies?
The studies provided do not detail specific outcomes, highlighting a gap in the current evidence.
What complications have been reported?
Safety data from the studies is limited, with no specific complications detailed in the provided evidence.
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.