Merit Medical ProGuide Chronic Dialysis Catheter - Manual

INTRODUCTION OF THE VALVED PEELAWAY INTRODUCER
CAUTION: The FlowGuard is not intended to create a complete two-way seal nor is it intended
for arterial use.
CAUTION: The FlowGuard is designed to reduce blood loss but it is not a hemostasis valve.
The valve will substantially reduce the rate of blood flow but some blood loss through the valve
will occur.
CAUTION: The FlowGuard will also reduce air intake. At 12 mmHg vacuum pressure the
FlowGuard introducer may allow up to 4 ml/sec of air to pass through the valve.
1. Remove the dilator from the peel-away sheath.
2. Slide the valve over the sheath opening.
3. Insert the dilator through the valve and
lock in place using the rotating collar.
NOTE - Optional dilation:
• To ease insertion of the peelaway introducer, some
physicians prefer to dilate the vein before
inserting the introducer.
• Thread the dilator(s) over the end of the guide wire
and advance into the vein using a rotating motion to
assist passage through the tissue.
CAUTION: As the dilator(s) pass through the tissue and
into the vasculature, ensure that the guide wire does not
advance further into the vein.
4. While maintaining guide wire position in the vein, advance the locked peelaway introducer and
dilator assembly over the exposed guide wire and into the vein.
WARNING: Never leave the sheath in place as an indwelling catheter. Damage to the vein will occur.
5. Hold the sheath in place and unlock the dilator assembly by turning the rotating collar. Gently
withdraw the dilator and wire from the sheath leaving the valved introducer in place.
CAUTION: Care should be taken not to advance the split sheath too far into the vessel as a
potential kink would create an impasse to the catheter.
DIALYSIS CATHETER PLACEMENT
1. Advance the distal section of the catheter through the valved sheath introducer and into the vein.
PRECAUTION: To help minimize catheter kinking, it may be necessary to advance in small steps
by grasping the catheter close to the sheath.
2. Advance the catheter tip to the junction of the
superior vena cava and right atrium.
3. With the catheter advanced and positioned, crack the
sheath handle in half and peel the non-valved side of the
handle partially away from the catheter.
CAUTION: Do not pull apart the portion of the sheath that
remains in the vessel. To avoid vessel damage, pull back
the sheath as far as possible and peel the sheath only a few
centimeters at a time.
4. Peel the non-valved side of the handle partially away from the catheter.
5. Near the valve, hold the catheter firmly in
position and pull the valve off the catheter.
PRECAUTION: It is normal to experience
some resistance while pulling the
catheter through the slit on the valve.
6. Remove the sheath completely from the
patient and catheter.
7. Press the remaining catheter loop
(“knuckle”) gently into the subcutaneous
pocket created at the venous entry site.
WARNING: Catheters should be implanted
carefully to avoid any sharp or acute
angles which could compromise the flow
of blood or occlude the opening of the
catheter lumens.
PRECAUTION: For optimal product performance do not insert any portion of the cuff into the vein.
8. Attach syringes to both extensions and open the clamps. Confirm correct placement and catheter
function by aspirating blood from both lumens. Flush each lumen with heparinized saline
(priming volume is printed on the extension tubing clamp). Blood should aspirate easily.
PRECAUTION: If either lumen exhibits excessive resistance to blood aspiration, the catheter may
need to be rotated or repositioned to obtain adequate blood flow.
PRECAUTION: It is recommended that the blue “venous” luer connection be oriented cephalad
(toward the head).
9. Clamp the extensions immediately after flushing.
10. Remove the syringes and replace with injection caps.
PRECAUTION: Avoid air embolism by keeping extension tubing clamped at all times when not in
use and by aspirating then irrigating the catheter prior to each use. Always aspirate first then
irrigate the catheter prior to each use. With each change in tubing connections, purge air from
the catheter and all connecting tubing and caps.
11. Correctly position the cuff and tunneled portion of the catheter.
12. Confirm proper tip placement with fluoroscopy. The distal “venous” tip should be positioned at
the level of the caval atrial junction or into the right atrium to ensure optimal blood flow
WARNING: Failure to verify catheter placement with fluoroscopy may result in serious trauma or
fatal complications.
13. Secure and dress the catheter as noted in “Securement and Dressing”
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 divid-
ed 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.
The FlowGuard™ Valved Peelable Introducer is intended for use in the percutaneous insertion of
catheters into the venous system.
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.
• The FlowGuard Valved Peelable Introducer is not designed for use in the arterial system or
as a hemostatic device.
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 • Hemotoma
• 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
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Merit Medical Systems, Inc. South Jordan, Utah 84095 • U.S.A. 1-801-253-1600
U.S.A. Customer Service 1-800-356-3748
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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 prefered anatomical location for chronic dialysis catheters.
However, the left internal jugular vein, as well as the external jugular veins, subclavian veins,
femoral veins and occasionally a translumbar approach directly into the inferior vena cava 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 INETRNAL 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.
SITE PREPARATION
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. Prepare and maintain a sterile field throughout the procedure using standard institutiional
protocol for implantable devices.
PRECAUTION: Follow Universal Precautions when inserting and maintaining this device.
Due to the risk of exposure to bloodborne pathogens, health care professionals should always
use standard blood and body fluid precautions in the care of all patients. Sterile technique
should always be followed.
4. 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.
5. Prepare the sterile field and access site using an approved prep solution and standard
surgical technique.
PRECAUTION: Use standard hospital protocols when applicable.
6. The patient should be placed in a modified Trendelenburg position, with the upper chest
exposed and the head turned slightly to the opposite side of the insertion site.
7. For internal jugular placement, have patient lift his/her head from the bed to define the
sternomastoid muscle. The venous entry site will be performed at the apex of a triangle formed
between the two heads of the sternomastoid muscle. The apex should be approximately three
finger breadths above the clavicle.
8. (If applicable) Administer local anesthesia to the insertion site and the path for the
subcutaneous tunnel.
INSERTION TECHNIQUE (1) - COMMON STEPS
PERCUTANEOUS ENTRY INTO RIGHT INTERNAL JUGULAR VEIN
WITH A VALVED PEELAWAY SHEATH INTRODUCER
VENOUS ACCESS AND GUIDE WIRE INSERTION
1. K-DOQI Guidelines recommend the use of ultrasound guidance. Insert the introducer needle
with an attached syringe and advance it into the target vein, in the direction of blood flow.
Aspirate gently as the insertion is made. Aspirate a small amount of blood to ensure the needle
is correctly positioned in the vein.
PRECAUTION: If arterial blood is aspirated, remove the needle and apply immediate pressure to
the site for at least 15 minutes. Ensure that the bleeding has stopped and that no hematoma has
developed before attempting to cannulate the vein again.
NOTE: Mini access (“micropuncture”) is recommended. Follow manufacturers guidelines for
proper insertion technique.
2. When the vein has been entered, remove the syringe leaving the needle in place and place
thumb over the hub of the needle to minimize blood loss and / or air embolism.
3. Insert the distal end of the marker guide wire into the needle hub (or mini access
introducer hub) and pass it into the vasculature.
PRECAUTION: If using the “J” tipped wire provided, draw the tip of the wire back into the
straightener so that only the tip of the wire is exposed.
4. Advance the guide wire with forward motion until the tip resides in the vena cava.
WARNING: Cardiac arrhythmias may result if the guide wire is allowed to pass into the right atrium.
CAUTION: Do not advance the guide wire or catheter if unusual resistance is encountered.
CAUTION: Do not insert or withdraw the guide wire forcibly from any component. The wire may
break or unravel. If the guide wire becomes damaged and must be removed while the needle
(or sheath introducer) is inserted, the guide wire and needle should be removed together.
PRECAUTION: The length of the guide wire inserted is determined by the size of the patient and
the anatomical site used.
PRECAUTION: Depth markings on the wire will help determine indwelling depth. Always
confirm proper guide wire position using fluoroscopy.
5. Remove the needle (or mini access introducer), leaving the guide wire in place. The guide wire
should be held securely during the procedure. The introducer needle must be removed first.
CATHETER PREPARATION AND SUBCUTANEOUS TRACT DILATION
1. Remove the stiffening stylet from the venous lumen.
PRECAUTION: The ProGuide catheter is packaged with a guide wire stiffening stylet to facilitate
placement using the over-the-wire technique and is not used with a peelaway introducer
insertion technique (see insertion technique 2).
2. Irrigate each lumen of the catheter with heparinized saline and clamp each extension prior to
catheter insertion.
WARNING: To minimize the risk of air embolism, keep the catheter clamped at all times when
not in use or when attached to a syringe, IV tubing, or bloodlines.
WARNING: Patients requiring ventilator support are at increased risk of pneumothorax during
subclavian vein cannulation.
CAUTION: Do not clamp the dual lumen portion of the catheter body. Clamp only the clear
extension tubing.
PRECAUTION: Only clamp the catheter with the in-line tubing clamps provided.
3. Determine the catheter exit site on the chest wall, approximately 8-10 cm below the clavicle that
is below and parallel to the venous puncture site.
PRECATUION: A tunnel with a wide, gentle arc lessens the risk of catheter kinking. The distance
of the tunnel should be short enough to keep the bifurcated junction from entering the exit site,
yet long enough to keep the cuff 2-3 cm (minimum) from the skin opening site.
4. Make a small incision at the desired exit site of the tunneled catheter on the chest wall. The
incision should be wide enough to accommodate the cuff, approximately 1 cm.
5. Use blunt dissection to create the subcutaneous tunnel opening at the catheter exit site for
the white tissue ingrowth cuff, midway between the skin exit site and the venous entry site,
approximately 2-3 cm (minimum) from the catheter exit site.
WARNING: Do not over-expand the subcutaneous tissue during tunneling. Over-expansion may
delay or prevent cuff in-growth.
6. Make a second incision above the first, at the venous insertion site. Enlarge the cutaneous
site with a scalpel and create a small pocket with blunt disection to accommodate the small
remaining catheter loop (“knuckle”) of the catheter after the peel-away sheath is removed.
7. Attach the tunneler to the catheter’s venous lumen. Slide the tip of the catheter over the tri-ball
connection until it rests adjacent to the sheath stop.
8. Slide the tunneler sheath over the catheter making certain that the sleeve covers the arterial
lumen. This will reduce the drag in the subcutaneous tunnel as the apparitional bump and
arterial port pass through the tissue.
9. With the blunt tunneler, gently lead the catheter and tunneler connection into the exit site and
create a subcutaneous tunnel from the catheter exit site to emerge at the venous entry site.
CAUTION: The tunnel should be made with care to avoid damage to surrounding vessels. Avoid
tunneling through muscle.
CAUTION: Do not pull or tug the catheter tubing. If resistance is encountered, further blunt
dissection may facilitate insertion. The catheter should not be forced through the tunnel.
10. After tunneling the catheter, the tunneler can be removed by sliding the tunneler sheath away
from the catheter and pulling the tunneler from the distal tip of the catheter.
CAUTION: Avoid damage to the catheter by using a slight twisting motion.
CAUTION: To avoid damage to the catheter tip, keep the tunneler straight and do not
pull it out at an angle.
N
Pull valve and
sheath off
Hold catheter
in position
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