Bard BI-DIRECTIONAL and KELLY-WICK Tunnelers Instructions for Use Rev 2 July 2018 .pdf
BARD® BI-DIRECTIONAL and KELLY-WICK
Instructions For Use
PK0114100 Rev. 2 07/18
BARD® Bi-Directional and Kelly-Wick Tunnelers
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
INSTRUCTIONS FOR USE
The BARD® Bi-Directional and Kelly-Wick Tunnelers are intended to aid in creating subcutaneous tunnels
for the placement of vascular prostheses (grafts) or autogenous grafts for arteriovenous access, peripheral
vascular, and extra-anatomic bypass procedures.
The Kelly-Wick tunneler consists of two components: a shaft with integral handle and a tip. The BARD®
Bi-Directional tunneler consists of three components: a shaft, a separate handle and a tip. When the
components are assembled they create a single unit device.
The Tunneler components are reusable medical devices, and are made of medical grade stainless steel.
1. Care should be exercised to protect the BARD® Bi-Directional and Kelly-Wick Tunnelers from mechanical
damage. Rough handling may mar the surface of the tunnelers. The BARD® Bi-Directional and KellyWick Tunnelers are fabricated from stainless steel. These devices will stand up to repeated use if
proper care is exercised.
2. Do not soak instruments in saline or bleach solutions, which may damage the surface of the
3. The BARD® Bi-Directional and Kelly-Wick Tunnelers are supplied non-sterile and require complete
disassembly prior to cleaning.
4. The BARD® Bi-Directional and Kelly-Wick Tunnelers must be thoroughly cleaned, inspected and
sterilized prior to each use.
5. Do not soak instruments in saline or bleach solutions which may damage the surface of the instruments.
6. Bard Peripheral Vascular does not recommend sterilizing the BARD® Bi-Directional or Kelly-Wick
Tunnelers with ethylene oxide or flash sterilization.
Cleaning Prior to Sterilization
Decontamination and sterilization prior to use are the responsibility of the hospital facility as the
Tunneler is sold non-sterile.
Personnel should wear appropriate protective attire when handling the BARD® Bi-Directional and Kelly-Wick
Tunneler components. If the hospital is not equipped with a combination instrument washer-sterilizer, the
following procedure should be followed:
1. Immediately after use, completely disassemble the Tunneler and rinse the components in warm water to
assist in the removal of visible debris.
2. If the final wash is to be delayed, the tunneler should be immersed in warm water containing an
effective neutral pH (pH = 7) blood solvent or detergent. Reference PRECAUTION #5.
3. It is important to inspect all components of the BARD® Bi-Directional and Kelly-Wick Tunnelers, even
those not used in the surgical procedure, to ensure that the entire set is washed and clean prior to
4. Use a neutral pH, low sudsing detergent during the wash. It is important to remove all particles of
adhering tissue and dried blood from the crevices of the device, particularly on the threaded portions
of the shafts and bullet tips and the knurling on the handle. Use only specially recommended stainless
steel wire brushes or stiff plastic brushes for cleaning. Avoid using ordinary soap which may leave
insoluble alkali films and abrasives, which may roughen the metallic surfaces.
5. Immediately after washing, the Tunneler should be rinsed with hot water for a brief period and then
6. It is important to inspect all Tunneler components and the Tunneler Sterilization Cassette to insure that
they are clean and free of damage prior to sterilization. Damage that could prevent proper function
of the Tunneler includes scratches, cross-threading, etching, pitting, burrs, nicks, dents or cracks.
Reference PRECAUTIONS #1 and #4.
After cleaning and decontamination, all components should be placed in an appropriate sterilization
cassette that must be enclosed in an appropriate commercially available sterilization wrap, used in
accordance with the wrap manufacturer’s instructions.
NOTE: Bullet tips are small. The holes in the cassette should not allow any of the parts to fall out.
Proper maintenance of the Tunnelers requires careful handling of the devices to avoid damaging the
threaded portions. If these areas are damaged through improper handling (i.e., dropping, cross-threading,
brushing with abrasives), the parts may not fit together properly or be interchangeable on the shafts. If
such damage occurs, contact Bard Peripheral Vascular for appropriate replacement parts and ordering
If the instrument will not be completely cleaned manually as previously described, it should be rinsed and
pre-cleaned of all debris prior to placing it in a combination washer/sterilizer. Follow your washer/sterilizer
equipment manufacturer’s instructions for minimum exposure requirements for surgical instruments.
Recommendations for Steam Sterilization
The BARD® Bi-Directional and Kelly-Wick Tunnelers and all associated accessories are made of stainless
steel and, after appropriate cleaning and decontamination, may be repeatedly exposed to methods of
sterilization utilizing steam without compromising the physical properties of the device. This device is not
considered a terminally sterilized medical device, but rather, a reusable medical device.
After cleaning and decontamination, the BARD® Bi-Directional and Kelly-Wick Tunnelers may be
sterilized following your saturated steam sterilizer equipment manufacturer’s instructions for minimum
exposure requirements for surgical instruments or by using the following cycle parameters. Reference
Temperature: 250° F (121° C)
15 psi (1.034 BAR)
Prior to opening the sterilization wrap, inspect the wrap for tears, pinholes, or other damage that might
compromise sterility. The Cassette must be enclosed in an appropriate commercially available sterilization
wrap in order to preserve sterility after processing. The following standards/guidelines may be referenced
for further information on the safe handling and biological cleaning and sterilization of medical devices:
“Recommended Practices for Cleaning and Caring for Surgical Instruments and Powered Equipment,”
AORN Journal, March 2002, Vol. 75, No. 3, pp. 627-641.
AAMI/ANSI/ISO 11134 “Sterilization of health care products - Requirements for validation and routine
control - Industrial moist heat sterilization.”
ANSI/AAMI ST35-1996 “Good Hospital Practice: handling and biological decontamination of safe medical
devices in health care facilities and in non-clinical settings.”
Selection of Tips
The Tunneler bullet tips are interchangeable. They are available in a variety of sizes. To create the
appropriately sized tunnel for a chosen specific graft configuration, use the following guidelines for bullet
For natural vessels, unsupported ePTFE or polyester vascular grafts and similar products, select a bullet
tip of the same size as the internal diameter (ID) of the graft being implanted.
For bypass grafts with external spiral support such as Flex Small beading, IMPRA FLEXTM grafts,
CENTERFLEXTM grafts, BARD® polyester grafts or similar products with external support, select a bullet tip
one or two millimeters larger than the internal diameter of the graft being implanted. For example, when
implanting a 6 mm ID graft, use the 7 mm or 8 mm bullet tip to create the tunnel. Switch to a tip of the
same size as the internal diameter (ID) of the graft prior to pulling the graft through the tunnel.
The hollow 4 mm vein tip may be used with the luer lock adapter for injection of heparin and contrast fluid,
instillation of vasolytic agents, and placement of small veins.
Selection of Tunneler Shafts
The shafts measure 6 mm in diameter and are available in several lengths and configurations (straight and
curved). All BARD® Bi-Directional Tunneler shafts are designed such that the detachable handle and bullet
tips will fit on either end of the shaft. Select a shaft of appropriate length and configuration that creates the
proper subcutaneous tunnel for graft placement.
Directions for use:
1. Select the appropriate bullet tip and shaft. If using the BARD® Bi-Directional Tunneler attach the handle
to one end of the shaft. Screw the bullet tip securely onto the other end of the tunneler by hand.
2. Follow standard surgical practice to create entrance and exit incisions for the Tunneler.
3. Use the sterile assembled Tunneler to create a tissue tunnel connecting the entrance and exit incisions.
4. When the tunneler passes through the incision exit site and a satisfactory tunnel has been created,
place the graft over a bullet tip that matches the internal diameter of the graft. Secure the graft on
the bullet tip by tying a suture at the waist of the bullet tip, or use the suture hole at the base of the tip
to aid in securing the graft. The BARD® Bi-Directional Tunneler provides for the option of pulling the
graft through the tunnel in the same direction the tunnel was created. To use this option, observe the
a. When the tunneler passes through the incision exit site and a satisfactory tunnel has been created,
remove the handle and bullet tip from the shaft.
b. Secure the handle on the end of the shaft where the bullet tip was just removed. Ensure the shaft
mates to the handle (i.e., the shaft cannot rotate) prior to tightening the handle base.
c. Select a bullet tip that matches the internal diameter of the graft and attach it to the other end of the
shaft. Secure the graft on the bullet tip by tying a suture at the waist of the bullet tip, or use the
suture hole at the base of the tip to aid in securing the graft.
5. Pull the graft through the tunnel using the handle.
6. When the graft has been pulled into position in the tunnel, remove the graft from the Tunneler by cutting
the suture or graft.
7. Proceed with making the vascular anastomoses.
Bard Peripheral Vascular warrants to the first purchaser of this product that this product will be free from
defects in materials and workmanship for a period of one year from the date of first purchase and liability
under this limited product warranty will be limited to repair or replacement of the defective product, in Bard
Peripheral Vascular’s sole discretion or refunding your net price paid. Wear and tear from normal use or
defects resulting from misuse of this product are not covered by this limited warranty.
TO THE EXTENT ALLOWABLE BY APPLICABLE LAW, THIS LIMITED PRODUCT WARRANTY IS
IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT
LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE. IN NO EVENT WILL BARD PERIPHERAL VASCULAR BE LIABLE TO YOU FOR ANY
INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM YOUR HANDLING OR
USE OF THIS PRODUCT.
Some countries do not allow an exclusion of implied warranties, incidental or consequential damages. You
may be entitled to additional remedies under the laws of your country.
An issue or revision date and a revision number for these instructions are included for the user’s
information on the last page of this booklet. In the event 36 months have elapsed between this date and
product use, the user should contact Bard Peripheral Vascular to see if additional product information is
Bard and IMPRA are registered
trademarks of C. R. Bard, Inc. or an
IMPRA Flex and CenterFlex are
trademarks of C. R. Bard, Inc. or an
Consult Instructions For Use
Copyright ©2018 C. R. Bard, Inc.
All rights reserved. Printed in the
Kelly-Wick 4mm Vein Tip and Luer Adapter
Kelly-Wick 23cm 120° Curved Shaft
Kelly-Wick 4mm Bullet Tip
Kelly-Wick 6mm Bullet Tip
Kelly-Wick 23cm 180° Curved Shaft
Kelly-Wick 7mm Bullet Tip
Kelly-Wick 55cm 60° Curved Shaft
Kelly-Wick 8mm Bullet Tip
Kelly-Wick 10mm Bullet Tip
Kelly-Wick 200 Cassette
Kelly-Wick 12mm Bullet Tip
Kelly-Wick 23cm Straight Shaft
Kelly-Wick 2000 Set
Kelly-Wick 23cm 60° Curved Shaft
Bi-Directional Bullet Tip
Bi-Directional Vein Tip
Bi-Directional Luer Adapter
Bi-Directional Tunneler 25cm Curved Shaft
Bi-Directional Tunneler 24cm Straight Shaft
Bi-Directional Tunneler 55cm Curved Shaft
Bi-Directional Tip Plate
Bard Peripheral Vascular, Inc.
1625 West 3rd Street
Tempe, AZ 85281
PK0114100 Rev. 2 07/18