Merit Medical ProGuide Chronic Dialysis Catheter - Manual (Page 3)

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.
SITE PREPARATION
1. 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.
2. 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.
3. Prepare and maintain a sterile field throughout the procedure using standard institutional 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. Prepare the sterile field and access site using an approved prep solution and standard
Surgical technique.
PRECAUTION: Use standard hospital protocols when applicable.
5. (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.
NOTE: Mini access (“micropuncture”) is recommended. Follow manufacturer’s guidelines for proper
insertion technique.
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.
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 at the junction of the superior vena
cava and right atrium.
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 for use of stiffener component).
2. Irrigate each lumen of the catheter with heparinized saline and clamp each extension prior to
catheter insertion.
WARNING: The heparin solution must be aspirated out of both lumens immediately prior to using the
catheter to prevent systemic heparinization of the patient.
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.
PRECAUTION: 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.