Mahurkar Subclavian Catheter Insertion Kit

FDA-Cleared Indications

• Percutaneous catheterization of the subclavian vein to establish central venous access.
• Use when central venous access is required for administration of fluids, medications, or other prescribed therapies.
• Use for hemodialysis access when the catheter configuration and labeling support that application.

Clinical Applications

• Percutaneous subclavian venous catheter placement.
• Temporary or longer-term central venous access when clinically indicated.
• Central access for hemodialysis when the labeled catheter configuration is appropriate.
• Administration of prescribed intravenous fluids or medications through central venous access.

Reported off-label uses

• Use as a bridge to creation or maturation of a permanent dialysis access, when selected by the treating team.
• Use for selected central venous infusions beyond the specific labeled therapy, based on catheter specifications and institutional policy.

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

• Available catheter sizes and lumens vary; the selected configuration should match the patient's anatomy, prescribed therapy, required flow rate, and dialysis equipment.
• Insertion is generally performed with sterile technique and imaging or anatomic guidance. Subclavian access carries risks including pneumothorax, arterial injury, bleeding, thrombosis, malposition, and infection.
• Confirm compatibility with dialysis machines, infusion equipment, connectors, medications, and required flow rates before use.
• MRI safety depends on the exact catheter components and any retained or attached accessories. Review the current manufacturer labeling and MRI conditions before scanning.
• Potential contraindications or precautions include infection at the access site, thrombosis or occlusion of the target vein, significant bleeding risk, altered anatomy, and inability to maintain sterile placement.