📊 Evidence-Based Reference
Usci Coronary Infusion Catheter
Summary: The USCI Coronary Infusion Catheter by C.R. Bard is a Class 2 medical device cleared by the FDA for coronary infusion applications. Key evidence includes studies on pharmacological atrial defibrillation and synchronized coronary sinus retroperfusion.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K891069 ↗
Decision Date ?
August 9, 1989
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The USCI Coronary Infusion Catheter was cleared through the FDA 510(k) pathway on August 9, 1989. It is manufactured by C.R. Bard and classified as a Class 2 device.
What It Is
The USCI Coronary Infusion Catheter is designed for the infusion of therapeutic agents into the coronary vasculature. It is used in procedures requiring precise delivery of medications to the heart.
FDA-Cleared Indications
- Percutaneous infusion of therapeutic agents into the coronary vasculature.
- Use in coronary infusion procedures requiring catheter-directed delivery of medication.
Clinical Applications
- Infusion of therapeutic agents into the coronary arteries or coronary circulation.
- Catheter-directed drug delivery during pharmacological atrial defibrillation procedures.
- Coronary sinus retroperfusion procedures.
- Other coronary infusion procedures within the device's FDA-cleared labeling.
Evidence Summary
The literature includes five studies ranging from 1986 to 2000, covering various clinical applications such as atrial defibrillation and coronary sinus retroperfusion. Study types include case reports and clinical trials.
Reported Outcomes
Published studies report successful pharmacological atrial defibrillation and effective coronary sinus retroperfusion using the catheter. These interventions have shown potential in supporting ischemic myocardium and treating acute cardiac conditions.
Safety Profile
Reported complications include inadvertent balloon extrusion and potential risks associated with catheter insertion. Safety profiles vary depending on the specific clinical application.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of recent studies. Further research is needed to establish long-term efficacy and safety across diverse patient populations.
Practical Considerations
- The available FDA record identifies the device category and intended coronary infusion use but does not provide complete specifications for catheter diameter, length, lumen configuration, or compatible guidewire size.
- Use requires image guidance and appropriate vascular access, with catheter selection based on the target vessel, anatomy, and treatment plan.
- Confirm compatibility with the intended infusion agent, connectors, pressure limits, and other procedural equipment before use.
- MRI safety status should be verified from the current device labeling or manufacturer because this historical FDA record does not establish MR Safe, MR Conditional, or MR Unsafe status.
- Potential contraindications and complications include allergy to the infusion agent or contrast, vascular injury, bleeding, thrombosis, arrhythmia, infection, and coronary dissection or perforation.
Frequently Asked Questions
What are the clinical indications for USCI Coronary Infusion Catheter?
The catheter is indicated for use in coronary infusion procedures, including pharmacological atrial defibrillation and coronary sinus retroperfusion.
What outcomes have been reported in clinical studies?
Studies have reported successful atrial defibrillation and myocardial support during ischemic events using the catheter.
What complications have been reported?
Safety data indicate risks such as balloon extrusion and complications related to catheter insertion.
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.