Merit Medical ProGuide Chronic Dialysis Catheter - Manual (Page 2)

I N S T R U C T I O N S F O R U S E
DESCRIPTION
The ProGuide Chronic Hemodialysis Catheter is made of soft radiopaque polyurethane called Carbotane®.
It is available in 14.5 French size and a variety of lengths. The catheter shaft is divided internally into two
separate lumens by a septum. It allows flow rates as high as 500 mL/min. The catheter has a white tissue
ingrowth cuff to help anchor the catheter in position.
INDICATIONS FOR USE
The ProGuide Chronic Dialysis Catheter is indicated for use in attaining long-term vascular access for
hemodialysis and apheresis.
It may be implanted percutaneously and is primarily placed in the internal jugular or subclavian vein of an
adult patient.
Catheters greater than 40 cm are intended for femoral vein insertion.
GENERAL CAUTION STATEMENTS
• Read instructions for use carefully before using device.
• RX ONLY - Federal Law (USA) restricts the device to sale by or on the order of a physician.
• Single Patient Use Only
• Sterilized by Ethylene Oxide (EO)
• Sterile and non-pyrogenic only if packaging is not opened, damaged or broken.
• Do not resterilize the catheter or components by any method. The manufacturer will not
be liable for any damages caused by reuse of the catheter or accessories.
• Do not use the catheter or accessories if the packaging is open, damaged or compromised.
• Do not use the catheter or accessories if any sign of product damage is visible.
CONTRAINDICATIONS
• The ProGuide Chronic Dialysis Catheter is intended for long-term vascular access and should not be
used for any purpose other than indicated in these instructions.
POTENTIAL COMPLICATIONS
The use of an indwelling central venous catheter provides an important means of venous access for
critically ill patients; however, the potential exists for serious complications. Before attempting the insertion
of the ProGuide catheter, the physician should be familiar with the following complications and their
emergency treatment should they occur:
• Air embolism • Bacteremia
• Bleeding at site • Brachial plexus injury
• Cardiac arrhythmia • Cardiac tamponade
• Catheter or cuff erosion through the skin • Catheter embolism
• Catheter occlusion • Catheter damage due to compression between
• Central venous thrombosis the clavicle and first rib
• Catheter-related sepsis (septicemia) • Endocarditis
• Exit site infection • Exit site necrosis
• Extravasation • Exsanguination
• Fibrin sheath formation • Hematoma
• Hemorrhage • Hemothorax
• Hydrothorax • Inferior vena cava puncture
• Inflammation, necrosis or scarring of • Intolerance reaction to
skin over implant area implanted device
• Laceration of vessels or viscus • Lumen thrombosis
• Mediastinal injury • Perforation of vessels or viscus
• Pleural Injury • Pneumothorax
• Pulmonary emboli • Retroperitoneal bleeding
• Right atrial puncture • Spontaneous catheter tip malposition
• Subclavian artery puncture or retraction
• Thoracic duct injury (laceration) • Thromboembolism
• Thrombocytopenia • Tunnel infection
• Vascular (venous) thrombosis • Ventricular thrombosis
• Vessel erosion • Risks normally associated with local and general anesthesia,
surgery, and post-operative recovery
These and other complications are well documented in medical literature and should be carefully
considered before placing the catheter. Placement and care of hemodialysis catheters should be
performed by persons knowledgeable of the risks involved and qualified in the procedures.
INSERTION SITES
The right internal jugular vein is a preferred anatomical location for chronic dialysis catheters. However,
the left internal jugular vein, as well as the external jugular veins and subclavian veins can also be a
consideration. As with all invasive procedures, the physician will assess the anatomical and physiological
needs of the patient to determine the most appropriate catheter entry site. ProGuide is available in various
lengths to accommodate the varying anatomical differences of patients as well as the differences between
right and left side approaches. Catheters greater than 40 cm long are typically placed in the femoral vein.
PLACEMENT INTO RIGHT OR LEFT INTERNAL JUGULAR VEIN