Peripherally Inserted Central Venous Catheter
Catheter Technology
FDA Clearance Information
The peripherally inserted central venous catheter by Catheter Technology was cleared by the FDA via the 510k pathway on August 12, 1987. It is classified as a Class 2 device.
What It Is
FDA-Cleared Indications
- Prolonged intravenous administration of fluids, medications, or other therapeutic substances
- Central venous access when peripheral access is inadequate or repeated venipuncture should be avoided
Clinical Applications
- Long-term intravenous antibiotic therapy
- Administration of chemotherapy and other cancer treatments
- Delivery of parenteral nutrition
- Repeated intravenous medications or fluids requiring reliable central venous access
Reported off-label uses
- Administration of selected blood products or blood sampling when the catheter lumen and institutional protocols permit
- Extended outpatient intravenous therapy for conditions not specifically described in the individual product labeling
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
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- Common insertion sites include the basilic, brachial, or cephalic veins of the upper arm; the catheter tip is advanced toward the lower superior vena cava or cavoatrial junction.
- Catheter diameter, length, number of lumens, and maximum flow rate must match the prescribed therapy and the patient's venous anatomy.
- Use only compatible medications and flushing solutions; follow the manufacturer's instructions for placement confirmation, dressing changes, flushing, and maintenance.
- MRI safety depends on the specific catheter and any reinforcing components. Confirm the exact product's MR Safe, MR Conditional, or MR Unsafe labeling before scanning.
- Potential complications include infection, thrombosis, catheter occlusion, malposition, bleeding, venous injury, and catheter breakage or embolization. Avoid or use caution with severe upper-extremity venous thrombosis, local infection, or anatomy that prevents safe placement.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for peripherally inserted central venous catheter?
Indications include prolonged intravenous therapy for infections, chemotherapy, and parenteral nutrition.
What outcomes have been reported in clinical studies?
Studies report high efficacy in outpatient antibiotic therapy for spinal infections and successful use in pediatric leukemia.
What complications have been reported?
Complications include infections, thrombosis, and mechanical issues, though some studies report no complications in specific settings.