Mallinckrodt Medical Inc Infussion Catherter

FDA-Cleared Indications

• Percutaneous catheter access to the venous system for infusion of fluids, medications, or contrast media.
• Use during diagnostic or therapeutic procedures that require controlled delivery of an infused substance through a vein.

Clinical Applications

• Venous infusion during image-guided diagnostic procedures.
• Delivery of contrast media during venography or other venous imaging procedures.
• Administration of medications or therapeutic infusions through percutaneous venous access.
• Controlled infusion during interventional vascular procedures.

Reported off-label uses

• Delivery of thrombolytic medication during catheter-directed treatment of venous thrombosis, when compatible with the specific catheter and not included in its labeling.
• Infusion during selected endovascular treatments such as venous thrombectomy or venous stenting, when the catheter is used outside its cleared 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

• Confirm the catheter's labeled size, length, pressure rating, infusion rate, and compatibility with the medication, contrast agent, guidewire, sheath, and other equipment being used.
• Select an access site and catheter dimensions that match the patient's venous anatomy and the intended infusion location.
• Use sterile technique and appropriate imaging guidance to reduce the risk of infection, bleeding, thrombosis, vessel injury, malposition, and extravasation.
• MRI safety is not established by the information provided here; verify the exact catheter model and its current labeling before an MRI examination.
• Do not use when the patient has a contraindication to percutaneous venous catheterization or to the substance being infused; follow the product labeling and institutional protocol.