Bard Access Equistream Mode D'emploi

INSTRUCTIONS FOR USE
For Equistream* Straight and Alphacurve* Configuration Catheters
DESCRIPTION
The Equistream* and Equistream* XK catheters are made of radiopaque
polyurethane, and allow for flow rates as high as 500 ml/min. The catheter shaft
is divided internally into two separate lumens by a septum allowing hemodialysis
without the use of a "single needle" system. The catheter comes with a white
retention cuff for tissue ingrowth to anchor the catheter.
The Equistream* and Equistream* XK catheters have two separate free floating
tips, separated at a fixed point.
INDICATIONS FOR USE
The Equistream* and Equistream* XK long-term hemodialysis catheters
are indicated for use in attaining short-term or long-term vascular access for
hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the
internal jugular vein, external jugular vein, subclavian vein, or femoral vein. Catheters
longer than 40 cm are intended for femoral vein insertion.
CONTRAINDICATION
This device is contraindicated for patients exhibiting severe, uncontrolled
thrombocytopenia or coagulopathy.
WARNINGS
Vertebra
First Rib
Subclavian Vein
Internal Jugular Vein
Superior Vena Cava
Clavicle
Axillary Vein
Sternum
Pinch-off Area
Infraclavicular Fossa
to compression of the catheter between the first rib and clavicle and can lead to
damage or fracture and embolization of the catheter.
confirmation of catheter tip placement should be helpful in demonstrating that the
catheter is not being pinched by the first rib and clavicle.
• Alcohol or alcohol-containing antiseptics (such as chlorhexidine) may be used to
clean the catheter/skin site; however, care should be taken to avoid prolonged or
excessive contact with the solution(s). Solutions should be allowed to completely
dry before applying dressing.
• Acetone and Polyethylene Glycol (PEG)-containing ointments can cause failure
of this device and should not be used with polyurethane catheters. Chlorhexidine
patches or bacitracin zinc ointments (e.g., Polysporin* ointment) are the preferred
alternative.
• Follow Universal Precautions when inserting and maintaining this device.
• Cardiac arrhythmias may result if the guidewire and/or stylet touches the walls of
the right atrium. Use cardiac rhythm monitoring to detect arrhythmias.
• Close all clamps only in the center of the extension legs. Extensions may develop
cuts or tears if subjected to excessive pulling or contact with rough edges.
Repeated clamping near or on the Luer-lock connectors may cause tubing fatigue
and possible disconnection.
• Catheters should be implanted carefully.
• Any sharp or acute angles that could compromise the opening of the catheter
lumens need to be avoided.
• To prevent air embolism and/or blood loss put patient in Trendelenburg position
and always place thumb over the exposed orifice of the sheath introducer.
• To avoid damage to vessels and viscus, infusion pressures should not exceed
25 psi (172 kPa). The use of a 10 mL or larger syringe is recommended because
smaller syringes generate more pressure than larger syringes. Note: A three
pound (13.3 Newton) force on the plunger of a 3 mL syringe generates pressure in
excess of 30 psi (206 kPa) whereas the same three pound (13.3 Newton) force on
the plunger of a 10 mL syringe generates less than 15 psi (103 kPa) of pressure.
• Accessories and components used in conjunction with this catheter should
incorporate Luer-lock adapters.
• The heparin solution must be aspirated out of both lumens immediately prior to
using the catheter to prevent systemic heparinization of the patient.
• Failure to clamp extensions when not in use may lead to air embolism.
• In the rare event of a leak, the catheter should be clamped immediately. Necessary
remedial action must be taken prior to resuming dialysis or infusion procedure.
• The risk of infection is increased with femoral vein insertion.
• 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.
• Cannulation of the left internal jugular vein was reportedly associated with a higher
incidence of complications compared to catheter placement in the right internal
jugular vein. 7
• Alcohol should not be used to lock, soak or declot polyurethane Dialysis Catheters
because alcohol is known to degrade polyurethane catheters over time with
repeated and prolonged exposure.
• Intended for Single Use. DO NOT REUSE. Reuse and/or repackaging may
create a risk of patient or user infection, compromise the structural integrity and/
or essential material and design characteristics of the device, which may lead to
device failure, and/or lead to injury, illness or death of the patient.
CAUTIONS
• Repeated over tightening of blood lines, syringes and caps will reduce connector
life and could lead to potential connector failure. In case of damage, clamp
the catheter between the patient and the damaged area with a smooth-edged,
atraumatic clamp.
• Sterile and non-pyrogenic only if packaging is not opened, damaged or broken.
• Read the instructions for use carefully before using this device.
• CAUTION: Federal (USA) law restricts this device to sale by or on the order of a
physician.
• Left sided placement in particular, may provide unique challenges due to the right
angles formed by the innominate vein and at the left brachiocephalic junction with
the SVC. 5,8
• Care should be taken NOT to force the dilator sheath introducer assembly into the
vessel during insertion as vessel damage including perforation could result.
• Stylet is intended for use over a guidewire to aid in placement. Inserting the stylet
into the venotomy without tracking over a guidewire could result in vessel damage
including perforation.
• Failure to retract the stylet when inserting the tunneler into the catheter tip can
result in damage to the stylet.
• Ensure that the catheter does not move out of the vein while removing the
insertion stylet.
• Care should be taken not to advance the split sheath too far into vessel as a
potential kink would create an impasse to the catheter.
• Ensure that the introducer sheath is only torn externally. Catheter may need to be
further pushed into the vessel as sheath is torn.
• For optimal product performance, do not insert any portion of the cuff into the vein.
• If the microintroducer guidewire must be withdrawn while the needle is inserted,
remove both the needle and wire as a unit to prevent the needle from damaging or
English
WARNING: Percutaneous
insertion of the catheter should be
made into the axillary-subclavian
vein at the junction of the outer
and mid-thirds of the clavicle
lateral to the thoracic outlet. The
catheter should not be inserted
into the subclavian vein medially,
because such placement can lead
Fluoroscopic or radiographic
1
1
shearing the guidewire.
• Before attempting the insertion of Equistream* catheters, ensure that you are
familiar with the complications listed below and their emergency treatment should
any of them occur.
• The complications listed below as well as other complications are well
documented in medical literature and should be carefully considered before
placing the catheter. Placement and care of Equistream* catheters should be
performed by persons knowledgeable of the risks involved and qualified in the
procedures.
POSSIBLE 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 including the following:
• Air Embolism
• Arterial Puncture
• Bleeding
• Brachial Plexus Injury
• Cardiac Arrhythmia
• Cardiac Tamponade
• Catheter or Cuff Erosion Through
the Skin
• Catheter Embolism
• Catheter Occlusion
• Catheter Occlusion, Damage or Breakage
due to Compression Between the Clavicle
and First Rib
1
• C atheter-related Sepsis
• Endocarditis
• Exit Site Infection
• Exit Site Necrosis
• Extravasation
• Fibrin Sheath Formation
INSERTION TECHNIQUE (1) Percutaneous Placement Procedure of the
Equistream* catheter with cuff using the Bard Access Systems, Inc. split
sheath introducer:
For percutaneous placement, the catheter is inserted in either the subclavian
vein or internal jugular vein through a split sheath introducer. It has been
reported that right side, internal jugular placement is the preferred initial location
of consideration for percutaneous insertion.
Trendelenburg position with the head turned to the opposite side of the entry site.
A (COMMON STEPS).
CATHETERS MUST BE INSERTED UNDER STRICT ASEPTIC CONDITIONS.
WARNING: Cannulation of the left internal jugular vein was reportedly
associated with a higher incidence of complications compared to catheter
placement in the right internal jugular vein.
CAUTION: As reported in literature, left sided catheter placement may provide
unique challenges due to the right angles formed by the innominate vein and at
the left brachiocephalic junction with the SVC.
1. Provide a sterile field throughout the procedure. The operator should wear a
cap, mask, sterile gown, sterile gloves, and use a large sterile drape to cover the
patient.
2. Prepare the access site using standard surgical technique and drape the
prepped area with sterile towels. If hair removal is necessary, use clippers or
depilatories. Next, scrub the entire area preferably with chlorhexidine gluconate
unless contraindicated in which case povidone-iodine solution may be used.
Use a back-and-forth friction scrub for at least 30 seconds
blot. Allow antiseptic solution to air dry completely before puncturing the site.
3. (If applicable) Administer local anaesthesia to the insertion site and the path for
subcutaneous tunnel.
4. Flush each lumen with heparin solution prior to insertion and clamp the
extension legs. If using stylet, do not clamp the arterial (red) lumen until the
arterial insertion stylet and guidewire are removed. Clamping will kink the stylet
and prevent guidewire passage.
5. Insert the introducer needle with an attached syringe to the desired location.
Aspirate gently as the insertion is made.
6. When the vein has been entered, remove the syringe leaving the needle in
place.
7. If using a micropuncture set, insert the flexible end of the microintroducer
guidewire into the needle. Advance the microintroducer guidewire as far as
appropriate. Verify correct positioning, using fluoroscopy or ultrasound.
• Gently withdraw and remove the needle, while holding the guidewire in
position.
CAUTION: If the microintroducer guidewire must be withdrawn while the
needle is inserted, remove both the needle and wire as a unit to prevent
the needle from damaging or shearing the guidewire.
• Advance the small sheath and dilator together as a unit over the
microintroducer guidewire, using a slight rotational motion. Advance the
unit into the vein as far as appropriate.
• Withdraw the dilator and microintroducer guidewire, leaving the small
sheath in place.
WARNING: Place a thumb over the orifice of the sheath to minimize
blood loss and risk of air aspiration.
8. The standard guidewire can be inserted into the needle hub and passed through
the needle. Advance the standard guidewire to the desired location in the vessel.
9. If using a microintroducer, gently withdraw and remove the small sheath, while
holding the standard guidewire in position.
10. Remove the needle while holding the guidewire in place. Wipe the guidewire
clean and secure it in place.
CAUTION: Do not pull back standard guidewire over needle bevel as this could
sever the end of the guidewire. The introducer needle must be removed first.
11. Make a small incision at the insertion site. Make a second incision at the desired
exit site of the catheter.
12. B (Common Steps).
B (COMMON STEPS)
1. If using stylet, unscrew the stylet hub from the arterial
Luer-lock connector and retract stylet until it is no longer
visible at the arterial lumen tip.
CAUTION: Failure to retract the stylet when inserting the
tunneler into the catheter tip can result in damage to the
stylet.
2. With a tunneler, create a subcutaneous tunnel from the
catheter exit site to emerge at the venous entry site. If
using the Bard Access Systems, Inc. tunneler (see steps
1 to 3), attach the catheter to the tunneler so that the
catheter's venous tip slides over the barbed connection
and rests adjacent to the sheath stop. This allows the
catheter to be threaded through the tissue as the tunnel is
created. Slide the sheath found on the tunneler over the
venous tip/tunneler connection until it stops. In addition,
ensure the open end of sheath is covering the arterial
tip. This will reduce the drag on the arterial tip in the skin
tunnel and secure the catheter to the tunneler. (After positioning cuff, tunneler
can be removed by sliding sheath away from the catheter and pulling tunneler
from venous tip.) The catheter should not be forced through the tunnel.
3. Position the white retention cuff approximately midway between the skin exit site
and the venous entry site, 3 cm minimum, from the venous entry site. Detach
tunneler from catheter.
4. If using stylet, push the stylet back into catheter and tighten stylet hub onto
arterial catheter Luer-lock connector. Thread stylet tip into proximal side of the
venous end hole and allow stylet tip to protrude from tip of catheter.
1
• Hematoma
• Hemomediastinum
• Hemothorax
• Hydrothorax
• Inflammation, Necrosis or scarring
of skin over implant area
• Intolerance Reaction to Implanted Device
• Laceration of Vessels or Viscus
• Perforation of Vessels or Viscus
• P neumothorax
• Thoracic Duct Injury
• Thromboembolism
• Venous Stenosis
• Venous Thrombosis
• Ventricular Thrombosis
• Vessel Erosion
• Risks Normally Associated with Local
and General Anesthesia, Surgery, and
Post-Operative Recovery
6,9 The patient should be placed in
7
5,8
. Do not wipe or
10
Step 1.
Step 2.
Step 3.