📊 Evidence-Based Reference
Percutaneous Angiographic Needles
Mallinckrodt Critical Care
Summary: Percutaneous angiographic needles are used for vascular access in interventional radiology. They are primarily used in procedures requiring precise needle placement. Key evidence highlights their role in reducing radiation exposure during procedures.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K845037 ↗
Decision Date ?
June 21, 1985
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The percutaneous angiographic needles by Mallinckrodt Critical Care were cleared through the FDA 510(k) pathway on June 21, 1985. They are classified as Class 2 devices under product code DYB.
What It Is
Percutaneous angiographic needles are specialized devices used to gain vascular access for angiographic procedures. They facilitate the introduction of guidewires and catheters into the vascular system, essential for diagnostic and therapeutic interventions.
FDA-Cleared Indications
- Percutaneous access to blood vessels for angiographic procedures
- Needle access to facilitate the introduction of guidewires and catheters into the vascular system
Clinical Applications
- Obtaining arterial or venous access for diagnostic angiography
- Obtaining vascular access for catheter-based interventional procedures
- Facilitating guidewire placement during percutaneous vascular procedures
Evidence Summary
The literature includes 11 studies, comprising various study types such as RCTs and case series, published between 2014 and 2022. These studies explore different aspects of angiographic procedures, including technique innovations and radiation dose reduction.
Reported Outcomes
Published studies report that the use of percutaneous angiographic needles can facilitate complex procedures with reduced radial trauma and improved access. They are also associated with decreased radiation exposure when used with advanced imaging techniques.
Safety Profile
Reported complications include potential for vascular injury and infection at the puncture site. However, advancements in needle design and technique have mitigated many of these risks.
Evidence Limitations
The evidence is limited by the variability in study designs and small sample sizes in some studies. Further research is needed to standardize outcomes and assess long-term safety and efficacy.
Practical Considerations
- The needle size, length, and tip configuration should match the access vessel, patient anatomy, and planned guidewire or catheter.
- Access is generally performed using local anesthetic and imaging guidance, such as ultrasound and fluoroscopy, to improve placement accuracy.
- The needle must be compatible with the intended guidewire and access system; compatibility should be confirmed before use.
- Potential complications include bleeding, hematoma, infection, arterial dissection, pseudoaneurysm, and inadvertent injury to nearby structures.
- MRI safety depends on the specific needle materials and whether the device is being used during scanning. The individual product labeling should be reviewed; unused or retained needles should not be assumed to be MRI safe.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for percutaneous angiographic needles?
These needles are indicated for vascular access in procedures such as embolization and angioplasty.
What outcomes have been reported in clinical studies?
Studies report improved access and reduced trauma, with some evidence of decreased radiation exposure.
What complications have been reported?
Safety data indicate potential for vascular injury and infection, though these are mitigated by improved techniques.
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.