Infusion Catheter W Side Holes

FDA-Cleared Indications

• Delivery of fluids directly into the vascular system.
• Infusion of medications, contrast agents, or other therapeutic fluids through a percutaneously placed vascular catheter.

Clinical Applications

• Controlled vascular infusion during interventional radiology procedures.
• Delivery of contrast material during angiographic imaging.
• Administration of therapeutic fluids into a selected blood vessel when percutaneous vascular access is appropriate.
• Infusion procedures performed in hospital or procedural settings under imaging guidance.

Reported off-label uses

• Targeted intra-arterial chemotherapy or other regional drug delivery when the specific use is not included in the device labeling.
• Catheter-directed thrombolytic infusion for selected vascular thrombosis cases when the catheter and treatment plan are not specifically covered by the 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.

Practical Considerations

• The appropriate catheter diameter, length, tip configuration, and number or location of side holes depend on the access route, target vessel, infusion requirements, and vessel size.
• Compatibility with the introducer sheath, guidewire, injection system, contrast agent, medication, and other vascular devices should be confirmed before use.
• Insertion and positioning are typically performed with fluoroscopic or other imaging guidance by trained clinicians; incorrect placement can cause ineffective delivery, vessel injury, bleeding, or embolization.
• MRI safety cannot be determined from the FDA product code alone. The exact catheter model and labeling should be checked for MR Safe, MR Conditional, or MR Unsafe status before MRI.
• Potential complications include infection, bleeding, thrombosis, vessel perforation or dissection, catheter damage, and unintended infusion into an incorrect vessel. Contraindications and precautions depend on the patient's vascular access site, coagulation status, allergy history, and the intended infusate.