Bard Hickman User manual

Bard Access Systems, Inc.
Hickman*
Hemodialysis/Apheresis
Long Term Central
Venous Catheters
Instructions For Use

Table of Contents
Introduction 1
Indications For Use 3
Contraindications, Warnings, Cautions
and Precautions 3
Possible Complications 7
Hickman* Hemodialysis/Apheresis
Long Term Central Venous Catheter
Placement Procedures 8
Section A: Prepping Procedure
Section B: Tunneling Procedure
Section C: Cutdown Technique
Section D: Percutaneous Technique
Catheter Removal 17
References 18
Patient Information - Catheter Care
and Maintenance 19
Catheter Damage
Site Care
Clamping the Catheter
Flushing the Catheter and“Heparin Lock” Procedure
Changing the Injection Cap

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Introduction
Description:
Hickman* Hemodialysis/Apheresis Central Venous Catheters are
constructed of specially formulated and processed silicone. The catheters
are radiopaque with female luer locking adapters and SureCu* tissue
ingrowth cu for xation of the catheters in a subcutaneous tunnel. Each
catheter is provided in a double sterile package.
Catheter repair kits are available in sterile packages for the adapter legs.
Placement:
The catheter is placed into one of the large central veins so the tip lies in the
superior vena cava above the right atrium. It is tunnelled subcutaneously
to the desired exit site. The SureCu* Tissue Ingrowth Cu, attached to the
catheter, is positioned 3-5 cms below the skin exit site in the tunnel. The
cu promotes tissue ingrowth to secure the catheter in place.
Schematics:
Single Lumen
Connector
Attached Clamp
SureCuff*Tissue
ngrowth Cuff
Catheter
Protective Clamping Sleeve
Clamp He e

2
Adapter Legs
Attached Clamps
SureCu* Tissue
Ingrowth Cu
Catheter
Protective
Clamping
Sleeve
Clamp Here
Clamp Here
Dual Lumen

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Indications For Use
Hickman* Hemodialysis/Apheresis Catheters are designed for long-term
vascular access and for use in patients that lack adequate peripheral venous
access. They are available in single lumen (10.8 and 14.4 Fr), and a dual
lumen (13.5 Fr.), catheter congurations in various lengths.
All Hickman* Hemodialysis/Apheresis central venous catheters are
designed for hemodialysis, apheresis, and the administration of I.V. uids,
blood products, drugs, and parenteral nutrition solutions, as well as blood
withdrawal. The Hickman* dual lumen hemodialysis / apheresis catheter
incorporates two large, equal size lumens appropriate for hemodialysis and
apheresis procedures.
Contraindications, Warnings, Cautions
and Precautions
Contraindications
This device is contraindicated whenever:
• The presence of device related infection, bacteremia, or septicemia is
known or suspected.
• The patient’s body size is insucient to accommodate the size of the
implanted device.
• The patient is known or is suspected to be allergic to materials
contained in the device.
• Severe chronic obstructive lung disease exists (percutaneous
subclavian placement only.)
• Past irradiation of prospective insertion site.
• Previous episodes of venous thrombosis or vascular surgical
procedures at the prospective placement site.
• Local tissue factors will prevent proper device stabilization and/or
access.

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Warnings
• Intended for Single Patient Use. DO NOT REUSE. These products are
single use devices and should never be reimplanted. Reuse carries
with it the attendant concern of cross-infection regardless of the
cleaning or sterilization method. Resterilization of incompletely
cleaned devices may not be eective. Any device that has been
contaminated by blood should not be reused or resterilized.
• After use, this product may be a potential biohazard. Handle and
dispose in accordance with accepted medical practice and applicable
local, state and federal laws and regulations.
• Pinch-o Prevention: Catheters placed percutaneously or through a
cut-down, into the subclavian vein, should be inserted at the junction
of the outer and middle 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 to compression
of the catheter between the rst rib and the clavicle, which can
cause damage and even severance of the catheter. A radiographic
conrmation of catheter placement should be made to ensure that
the catheter is not being pinched by the rst rib and clavicle.1,2
First Rib
Subclavian Vein
Clavicle
Vertebra
nternal Jugular Vein
Superior Vena Cava
Sternum
Pinch-off Area
nfraclavicular Fossa
Axillary Vein
Signs of Pinch-O
Clinical:
• Diculty with blood withdrawal.
• Resistance to infusion of uids.
• Patient position changes required for infusion of uids or blood
withdrawal.

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Radiologic:
• Grade 1 or 2 distortion on chest X-ray.
Pinch-o should be evaluated for degree of severity prior to
explantation. Patients indicating any degree of catheter distortion
at the clavicle/rst rib area should be followed diligently. There are
grades of pinch-o that should be recognized with appropriate chest
x-ray as follows: 3,4
Grade Severity Recommended Action
Grade 0 No Distortion No Action
Grade 1 Distortion present without
luminal narrowing
Chest x-ray should be taken every one to three
months to monitor progression of pinch o
to grade 2 distortion. Shoulder positioning
during chest xrays should be noted as it can
contribute to changes in distortion grades.
Grade 2 Distortion present with luminal
narrowing
Removal of the catheter should be
considered.
Grade 3 Catheter transection or fracture Prompt removal of the catheter.
Cautions
• Carefully read and follow all instructions prior to use.
• Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician.
• Only qualied healthcare practitioners should insert, manipulate and
remove these devices.
Precautions
• Follow Universal Precautions when inserting and maintaining the
catheter.
• Follow all contraindications, warnings, cautions, precautions and
instructions for all infusates as specied by its manufacturer.
• Use aseptic techniques whenever the catheter lumen is opened
or connected to other devices. Povidone-iodine is the suggested
antiseptic to use with this device and components. Acetone and
tincture of iodine should not be used because they could adversely

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aect the performance of the catheter and connectors. 10% acetone/
70% isopropyl alcohol swabsticks used for dressing changes should
not adversely aect the catheter.
I. Prior to beginning placement procedure, do the following:
• Examine package carefully before opening to conrm its integrity and
that the expiration date has not passed. The device is supplied in a
double sterile package and is non-pyrogenic. Do not use if package is
damaged, opened or the expiration date has passed. Sterilized by
ethylene oxide. Do not Resterilize.
• Inspect kit for inclusion of all components.
• Fill (prime) the device with sterile heparinized saline or normal saline
solution to help avoid air embolism.
• When using an introducer kit, verify that the catheter ts easily through
the introducer sheath.
II. To avert device damage and/or patient injury during placement:
• Avoid accidental device contact with sharp instruments and
mechanical damage to the catheter material. Use only smooth-edged
atraumatic clamps or forceps.
• Avoid perforating, tearing or fracturing the catheter when using a
guidewire.
• Do not use the catheter if there is any evidence of mechanical
damage or leaking.
• Avoid sharp or acute angles during implantation which could
compromise the patency of the catheter lumen(s).
• If sutures are used to secure the catheter, make sure they do not occlude
or cut the catheter.
• When using percutaneous introducers:
- Carefully insert the introducer and catheter to avoid inadvertent
penetration to vital structures in the thorax.
- To avoid blood vessel damage, do not allow the percutaneous
introducer sheath to remain indwelling in the blood vessel
without the internal support of a catheter or dilator.
- Simultaneously advance the sheath and dilator with rotational
motion to help prevent sheath damage.

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III. After placement, observe the following precautions to avoid device
damage and/or patient injury:
• Do not use the catheter if there is any evidence of mechanical
damage or leaking. Damage to the catheter may lead to rupture,
fragmentation and possible embolism and surgical removal.
• Accessories and components used in conjunction with this device should
incorporate Luer lock connections.
• If signs of extravasation exist, discontinue injections. Begin appropriate
medical intervention immediately.
• Infusion pressure greater than 25 psi (172 kPa) may damage blood vessels
and viscus and is not recommended. DO NOT USE A SYRINGE SMALLER
THAN 10 mL!
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
• Bleeding
• Brachial Plexus Injury
• Cardiac Arrhythmia
• Cardiac Tamponade
• Catheter or Cu Erosion Through
Skin
• Catheter Embolism
• Catheter or Cu Occlusion
• Catheter Occlusion, Damage or
Breakage due to Compression
Between the Clavicle and First Rib
• Catheter-related Sepsis
• Endocarditis
• Exit Site Infection
• Exit Site Necrosis
• Extravasation
• Fibrin Sheath Formation
• Hematoma
• Hemothorax
• Hydrothorax
• Intolerance Reaction to Implanted
Device
• Laceration of Vessels or Viscus
• Perforation of Vessels or Viscus
• Pneumothorax
• Spontaneous Catheter Tip
Malposition or Retraction
• Thoracic Duct Injury
• Thromboembolism
• 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.

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Hickman* Hemodialysis /Apheresis Long-Term
Central Venous Catheter Placement Procedures
Section A: Prepping Procedure
Before beginning procedure, read the“Contraindications, Warnings,
Cautions and Precautions” and “Possible Complications” sections of
this manual.
1. Create sterile eld and open tray.
2. Prep venipuncture/cutdown area, tunnel and tunnel exit areas.
3. Perform local anesthetic inltration in venipuncture/cutdown, tunnel
and tunnel exit site areas.
4. Irrigate the catheter with sterile heparinized saline (100 u/mL) and
inspect for leakage. Clamp the catheter over the clamping sleeve(s).
5. Place patient in the Trendelenburg position with head turned away
from the intended venipuncture site.
Note: Refer to Section C or D Prior to Tunneling Procedure.
Section B: Tunneling Procedure
1. Measure catheter against chest wall of patient to determine desired
location of SureCu* Tissue Ingrowth Cu and exit site. Mark locations.
2. Tunneling procedure.
Note: The subcutaneous tunnel should be approximately 10 to 15 cm
long with the SureCu* Tissue Ingrowth Cu positioned in the tunnel.
The cu will be less prominent if positioned over an intercostal space.