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ProGuide™
chronic dialysis catheter
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 Carbothane®. 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.
Distal "Venous"Outflow Lumen
Proximal "Arterial" Inflow Lumen
Apposition "Bump"
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
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Read instructions for use carefully before using device.
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RX ONLY - Federal Law (USA) restricts the device to sale by or on the order of a physician.
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Single Patient Use Only
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Sterilized by Ethylene Oxide (EO)
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Sterile and non-pyrogenic only if packaging is not opened, damaged or broken.
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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.
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Do not use the catheter or accessories if the packaging is open, damaged or compromised.
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Do not use the catheter or accessories if any sign of product damage is visible.
CONTRAINDICATIONS
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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:
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Air embolism
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Bleeding at site
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Cardiac arrhythmia
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Catheter or cuff erosion through the skin
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Catheter occlusion
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Central venous thrombosis
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Catheter-related sepsis (septicemia)
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Exit site infection
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Extravasation
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Fibrin sheath formation
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Hemorrhage
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Hydrothorax
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Inflammation, necrosis or scarring of skin over implant area
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Laceration of vessels or viscus
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Mediastinal injury
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Pleural Injury
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Pulmonary emboli
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Right atrial puncture
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Subclavian artery puncture
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Thoracic duct injury (laceration)
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Thrombocytopenia
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Vascular (venous) thrombosis
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Vessel erosion
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
WARNING: Patients requiring ventilator support are at increased risk of pneumothorax during subclavian vein cannulation.
WARNING: Extended use of the subclavian vein may be associated with subclavian vein stenosis and thrombosis.
WARNING: The risk of infection is increased with femoral vein insertion.
WARNING: Failure to verify catheter placement with fluoroscopy may result in serious trauma or fatal complications.
PREPARATION INSTRUCTIONS
1.
Read instructions carefully before using this device. The catheter should be inserted, manipulated, and removed by a qualified, licensed physician or other
qualified health care professional under the direction of a physician.
2.
The medical techniques and procedures described in these instructions for use do not represent all medically acceptable protocols, nor are they intended as a
substitute for the physician's experience and judgment in treating any specific patient.
3.
The selection of the appropriate catheter length is at the sole discretion of the physician. To achieve correct tip placement, proper catheter length selection is
important. Routine fluoroscopy should always follow the initial insertion of this catheter to confirm appropriate placement prior to use.
Catheter Body
Implantable Cuff
Tubing Clamp
Extension Tubing
Suture Wing
Bifurcated Hub
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Bacteremia
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Brachial plexus injury
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Cardiac tamponade
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Catheter embolism
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Catheter damage due to compression between the clavicle and first rib
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Endocarditis
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Exit site necrosis
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Exsanguination
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Hematoma
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Hemothorax
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Inferior vena cava puncture
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Intolerance reaction to implanted device
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Lumen thrombosis
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Perforation of vessels or viscus
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Pneumothorax
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Retroperitoneal bleeding
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Spontaneous catheter tip malposition or retraction
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Thromboembolism
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Tunnel infection
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Ventricular thrombosis
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Risks normally associated with local and general anesthesia, surgery, and
post-operative recovery
English
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