📊 Evidence-Based Reference
Multipurpose Catheter
Advanced Cardiovascular Systems
Summary: The multipurpose catheter by Advanced Cardiovascular Systems is a versatile device used in various cardiovascular procedures. Key evidence highlights its utility in challenging anatomical scenarios.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K821189 ↗
Decision Date ?
July 8, 1982
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The multipurpose catheter was cleared by the FDA through the 510(k) pathway on July 8, 1982. It is manufactured by Advanced Cardiovascular Systems and classified as a Class 2 device.
What It Is
The multipurpose catheter is a flexible device designed for use in cardiovascular interventions. It facilitates access to difficult-to-reach areas within the vascular system, aiding in procedures such as coronary interventions and lead extractions.
FDA-Cleared Indications
- Percutaneous catheterization of blood vessels for diagnostic or therapeutic cardiovascular procedures.
- Delivery of contrast media or other fluids during vascular imaging and intervention.
- Use as an access or guiding catheter when selective catheterization of a vessel is required.
Clinical Applications
- Selective catheterization for cardiovascular angiography.
- Vascular access during percutaneous cardiovascular interventions.
- Delivery of contrast media for imaging blood vessels.
- Catheter-based access to vessels with difficult or angled anatomy.
Reported off-label uses
- Adrenal vein sampling.
- Transvenous access during lead extraction procedures.
- Use as an adjunct catheter during venous thrombectomy or venous stenting.
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 15 studies, comprising various study types such as case series and retrospective analyses, conducted between 2018 and 2023. These studies explore the catheter's application in diverse clinical settings.
Reported Outcomes
Published studies report the multipurpose catheter's effectiveness in facilitating coronary interventions, especially in anatomically challenging cases. It has also been shown to aid in successful adrenal vein sampling and lead extraction procedures.
Safety Profile
Reported complications include potential injury to veins or the heart during lead extraction and challenges in engaging certain vascular structures. However, specific adverse event rates are not detailed in the available studies.
Evidence Limitations
The evidence is limited by the lack of large-scale randomized controlled trials. Most studies are case series or retrospective analyses, which may introduce bias. Further research is needed to establish comprehensive safety and efficacy profiles.
Practical Considerations
- Available catheter size, length, tip shape, and lumen configuration vary by model; compatibility must be confirmed for the intended guidewire, sheath, contrast injector, or other device.
- The catheter is advanced under fluoroscopic or other appropriate imaging guidance and should not be forced if resistance is encountered.
- Potential complications include bleeding, hematoma, vessel injury, dissection, perforation, thrombosis, embolization, infection, arrhythmia, and contrast reactions.
- MRI safety depends on the exact catheter model and whether it contains metallic or other MRI-relevant components; verify the manufacturer's labeling before an MRI examination.
- Use is contraindicated or requires special caution in patients with uncorrectable bleeding risk, severe vessel disease, active infection at the access site, or known hypersensitivity to materials or contrast agents.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for the multipurpose catheter?
The multipurpose catheter is indicated for use in cardiovascular interventions, including coronary artery procedures and transvenous lead extractions.
What outcomes have been reported in clinical studies?
Studies report successful use in coronary interventions and lead extractions, particularly in anatomically challenging cases.
What complications have been reported?
Safety data indicate potential complications such as vascular injury during lead extraction, though specific rates are not detailed.
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.