📊 Evidence-Based Reference
Low Profile Port Attachable Catheter with Blue Flex Tip 8Fr Inroducer Kit Implantable Vascular Access System
Arrow Intl.
Summary: The low profile port attachable catheter with blue flex tip is an implantable vascular access system primarily used for long-term intravenous therapy. Key evidence includes its use in novel lesion crossing techniques and implantation in nonhuman primate models.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K981782 ↗
Decision Date ?
August 12, 1998
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared by the FDA through the 510(k) pathway on August 12, 1998. It is manufactured by Arrow Intl. and classified as a Class 2 medical device under product code DYB.
What It Is
The low profile port attachable catheter is an implantable vascular access system designed for long-term intravenous therapy. It features a blue flex tip and an 8fr introducer kit, facilitating ease of insertion and patient comfort.
FDA-Cleared Indications
- Long-term access to the central venous system for intravenous therapy.
- Use with an implantable vascular access port for repeated venous access.
- Placement using the included 8 Fr introducer kit and blue flex-tip catheter design.
Clinical Applications
- Long-term administration of intravenous medications through an implanted port.
- Repeated blood sampling through an implanted central venous access system.
- Long-term parenteral nutrition when central venous access is required.
- Repeated infusion therapy in patients who need reliable venous access.
Evidence Summary
The available literature includes two studies: one from 2018 evaluating a novel lesion crossing technique and another from 2001 involving a nonhuman primate model. These studies provide insights into the device's application and safety.
Reported Outcomes
Published studies report the efficacy of the device in facilitating novel endovascular techniques and its successful implantation in nonhuman primate models for pharmacokinetic studies. However, specific clinical outcomes in human populations are not detailed.
Safety Profile
Reported complications include common issues associated with vascular access devices, such as infection and thrombosis. The studies provided do not detail specific adverse events in human clinical settings.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed human clinical outcomes. Further research is needed to evaluate long-term safety and efficacy in diverse patient populations.
Practical Considerations
- The record identifies an 8 Fr introducer kit; confirm the catheter dimensions, length, port connection, and accessories in the current manufacturer instructions before use.
- Placement requires sterile technique and imaging or other appropriate guidance, with the catheter tip positioned in the central venous circulation according to institutional protocol.
- Confirm compatibility with the selected implantable port, infusion solution, pressure limits, and any power-injection requirements; do not assume all ports or catheters are interchangeable.
- MRI safety depends on the complete implanted system and its labeling. Verify the port, catheter, and any retained components before MRI.
- Potential complications include infection, thrombosis, catheter malposition, occlusion, vessel injury, bleeding, air embolism, and catheter or port damage.
Frequently Asked Questions
What are the clinical indications for low profile port attachable catheter?
The device is indicated for long-term intravenous therapy, including chemotherapy, parenteral nutrition, and frequent blood sampling.
What outcomes have been reported in clinical studies?
Studies report the device's efficacy in novel lesion crossing techniques and successful use in nonhuman primate models, but specific human clinical outcomes are not detailed.
What complications have been reported?
Reported complications include infection and thrombosis, common to vascular access devices, though specific human clinical data is limited.
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.