INDICATIONS FOR USE:
• The Medcomp® Soft-Line® Catheter is indicated for use in attaining Short-Term vascular access for Hemodialysis and Apheresis.
• It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
• Alternate insertion sites include subclavian vein or femoral vein as required.
• The curved Soft-Line® Catheter is intended for internal jugular vein insertion.
• This catheter is indicated for a duration less than (30) days. For femoral placement, monitor catheter condition closely.
CONTRAINDICATIONS:
• This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels.
WARNINGS:
• In the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove the catheter.
• Do not advance the guidewire or catheter if unusual resistance is encountered.
• Do not insert or withdraw the guidewire forcibly from any component. The wire may break or unravel. If the guidewire becomes damaged, the catheter and guidewire must be removed together.
• Federal Law (USA) restricts the device to sale by or on the order of a physician.