
1 Explanation of symbols on product or package
Refer to the package labels to see which symbols apply to this product.
Applicable symbol standards
• BS EN ISO 15223-1:2016: Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied
• IEC 60417: International Electrotechnical Commission, Graphical symbols for use on equipment
• ISO 7000: Graphical symbols for use on equipment
Symbol Reference Symbol title Explanatory text
ISO 15223-1
Clause 5.1.1
ISO 15223-1
Clause 5.2.8
ISO 15223-1
Clause 5.4.2
N/A Guide catheter/minimum
N/A Quantity Indicates the quantity of
ISO 15223-1
Clause 5.1.5
ISO 15223-1
Clause 5.1.4
ISO 15223-1
Clause 5.1.3
ISO 15223-1
Clause 5.2.3
ISO 15223-1
Clause 5.1.6
IEC 60417
Clause 5845
ISO 7000
Clause 3079
N/A Manufactured in Indicates the manufactur-
N/A For US audiences only Indicates the adjacent
ISO 15223-1
Clause 5.4.3
ISO 15223-1
Clause 5.4.3
Manufacturer Indicates the medical
Do not use if package is
damaged
Do not reuse Indicates a medical device
inner diamter
Lot Number Indicates the manufactur-
Use by date Indicates the date after
Date of manufacture Indicates the date when
Sterlized using ethylene
oxide
Catalogue number Indicates the manufactur-
Inner diameter To indicate a reference to
Open here To identify the location
Consult instructions for
use
Consult instructions for
use at this website
device manufacturer.
Indicates a medical device
that should not be used if
the package has been
damaged or opened.
that is intended for one
use, or for use on a single
patient during a single procedure.
Indicates the minimum
inner diameter of the guide
catheter.
devices present in the
package.
er’s batch code so that the
batch or lot can be identified.
which the medical device
is not to be used.
the medical device was
manufactured.
Indicates a medical device
that has been sterilized
using ethylene oxide.
er’s catalogue number so
that the medical device
can be identified.
the inner diameter
where the package can be
opened and to indicate the
method of opening it.
ing site of the device. A
manufacturing site is the
facillity where the product
is produced, transformed,
or assembled into a medical device.
text/symbology is intended
for US audiences only.
Indicates the need for the
user to consult the instructions for use.
Indicates the need for the
user to consult the instructions for use.
2 Description
The Telescope guide extension catheter is a single-lumen rapid exchange catheter. The guide extension catheter
is designed to act as an extension to a traditional guide catheter and to facilitate the delivery of interventional
devices into the vasculature. The guide extension catheter is intended to be used within the coronary and/or
peripheral vasculature to provide support.
The guide extension catheter is offered in sizes compatible with 6 Fr and 7 Fr guide catheters and is placed over
a guidewire.
The 150 cm guide extension catheter consists of a hydrophilic-coated, 25 cm single-lumen distal guide segment
connected to a stainless-steel polytetrafluoroethylene (PTFE) coated proximal pushwire. The 25 cm distal guide
segment contains 2 platinum-iridium radiopaque markers (Figure 1): 1 marker band located 2 mm from the distal
end, and another marker band located at the entry port opening. The proximal pushwire contains 2 positioning
marks, located at 90 cm (0.5 cm long) and 100 cm (1 cm long) from the distal tip. The guide extension catheter has
a tab at the proximal end of the pushwire that is used for device identification. The tab indicates guide catheter
compatibility and the resulting guide extension catheter inner diameter.
The hydrophilic coating is positioned on the distal section of the device for a length of approximately 21 cm from the
distal tip. Please refer to Chapter 8 for further information on how to prepare and use this device to ensure it
performs as intended. Failure to abide by the preparation for use instructions in this labeling might result in damage
to the device coating, which may necessitate intervention or result in serious adverse events.
The guide extension catheter is delivered through a guide catheter resulting in an overall inner diameter that is
approximately 1 Fr smaller than the guide catheter.
The guide extension catheter was sterilized with ethylene oxide.
Table 1. Product information
Telescope model num-
bers Telescope sizes
TELE6F 6 Fr 25 cm 6 Fr
TELE7F 7 Fr 25 cm 7 Fr
Telescope distal guide
segment length
Compatible guide catheter
3 Indications for use
Telescope guide extension catheter is intended to be used in conjunction with guide catheters to access discrete
regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
4 Contraindications
The guide extension catheter is contraindicated in the following situations:
• In vessels less than 2.5 mm in diameter
• In vessels in the neurovasculature or the venous system
5 Warnings
• For single-patient and single-procedure use only. Do not resterilize or reuse the device. Resterilization or
reuse can compromise device performance and increase the risk of inadequate resterilization and cross
contamination.
• Do not advance the guide extension catheter into a vessel without a leading guidewire because vessel damage
can occur.
• Do not advance the guide extension catheter into a vessel with an effective diameter less than 2.5 mm. Vessel
injury, ischemia, and occlusion can occur. If pressure in a vessel dampens after inserting the guide extension
catheter, withdraw the guide extension catheter until the pressure returns to normal.
• Use the guide extension catheter before the Use-by date specified on the package.
• Perform PTCA only at hospitals where emergency coronary artery bypass graft surgery can be performed in
the event of a potentially injurious or life-threatening complication.
• Do not apply torque to the guide extension catheter during delivery because catheter damage can occur.
Torquing the device can result in wire wrap or damage to the device or vessel.
• Due to the size and the nontapered tip of the guide extension catheter, use extreme care to avoid vessel
occlusion and damage to the wall of the vessels.
• If strong resistance is encountered during manipulation of the devices, do not force passage. Determine the
cause of the resistance before proceeding. If the cause cannot be removed, withdraw all the devices
simultaneously.
• Do not use the guide extension catheter if the packaging has been damaged. A damaged package could result
in a breach of sterility or device damage.
6 Precautions
• Inspect the guide extension catheter before use for any bends or kinks. Do not use a damaged catheter. Vessel
damage and inability to advance or withdraw the catheter can occur.
• Flush the guide extension catheter lumen with sterile, heparinized saline before use.
• Use caution when handling the guide extension catheter during a procedure to reduce the possibility of
accidental breakage, bending, or kinking.
• When the guide extension catheter is in the body, manipulate the catheter only under fluoroscopy. Do not
attempt to move the catheter without observing the resultant tip response, because catheter damage or vessel
injury can occur.
• Do not advance the guide extension catheter more than 15 cm beyond the tip of the guide catheter because
the guide extension catheter can become lodged in the guide catheter making it difficult to remove.
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• Do not withdraw an undeployed stent back into the guide extension catheter when the catheter is in the body,
because it can dislodge the stent. Instead, simultaneously pull both the guide extension catheter and
undeployed stent back into the guide catheter and remove them together.
• Do not inject contrast media solution at high pressure during the procedure.
• This device should be used only by physicians thoroughly trained in percutaneous, intravascular techniques
and procedures.
• Administer appropriate anticoagulation, antiplatelet, and vasodilator therapy to the patient.
7 Adverse effects
Potential issues that can be associated with the guide extension catheter include, but are not limited to, the
following adverse effects:
• Death
• Embolism
• Slow-flow
• Foreign body in patient
• Stent dislodgement
• Thrombus
• Vessel dissection
• Vessel perforation
• Occlusion (CVA/MI/spasm)
• Aneurysm
• Avulsion
• Reaction
• Infection
• Blood loss/hemorrhage/hematoma (vascular access complication)
• Renal failure (contrast induced nephropathy)
• Pulmonary infarct
• Tissue necrosis
The occurrence of the above listed complications may lead to the need for a surgical intervention.
8 Clinical procedure
8.1 Packaging contents
The package contains 1 guide extension catheter.
Other items that are required but not provided in the package:
• Guide catheter with an inner diameter large enough to accommodate the specific model of guide extension
catheter in use (refer to the label)
• Y-adaptor with hemostasis valve
• 0.36 mm (0.014 in) maximum outer diameter guidewire
• Sterile syringe (for flushing)
• Sterile heparinized saline (for flushing)
8.2 Preparation for use
1. Before use, carefully inspect the guide extension catheter packaging and components for damage.
2. Using sterile technique, transfer the dispenser coil with the guide extension catheter into the sterile field.
3. Remove the guide extension catheter from the dispenser coil. Thoroughly flush the guide extension catheter
lumen from the distal tip with sterile, heparinized saline solution.
Note: Flushing the device prior to use can help to reduce the risk of air embolism during insertion.
4. Immerse the 25 cm distal guide segment of the guide extension catheter in heparinized saline solution to
activate the hydrophilic coating.
Caution: Failure to activate the coating might result in damage to the device coating, which may necessitate
intervention or result in serious adverse events.
8.3 Delivery procedure
Deliver the guide extension catheter according to the following steps:
1. Secure the previously inserted guidewire and backload the distal tip of the guide extension catheter onto the
guidewire. Advance the guide extension catheter until the catheter is proximal to the hemostasis valve.
2. Open the hemostasis valve and advance the guide extension catheter through the hemostasis valve and into
the guide catheter. Ensure that the device distal segment fills with blood, to ensure that no air enters the
bloodstream.
3. Under fluoroscopy, advance the guide extension catheter beyond the distal tip of the guide catheter and into
the desired location within the vessel.
Warning: Do not advance the guide extension catheter into a vessel with an effective diameter less than
2.5 mm. Vessel injury, ischemia, and occlusion can occur. If pressure in a vessel dampens after inserting the
guide extension catheter, withdraw the catheter until the pressure returns to normal.
Do not advance the guide extension catheter more than 15 cm beyond the tip of the guide catheter
Warning:
as the guide extension catheter can become lodged in the guide catheter making it difficult to remove.
Warning: Due to the size and non-tapered tip of the guide extension catheter, use extreme care to avoid
vessel occlusion and damage to the wall of the vessels.
4. Use fluoroscopy to confirm the desired position of the guide extension catheter in the vessel.
5. If performing an interventional procedure, backload the interventional device over the existing guidewire.
Advance the device through the guide catheter and guide extension catheter into the desired vascular space.
Note: If a second wire is used during the intervention and encounters resistance within the guide catheter, pull
the wire back several centimeters and slowly re-advance.
6. Tighten the Y-adaptor hemostasis valve securely on the proximal shaft of the guide extension catheter to
prevent back-bleeding.
7. Perform the catheterization procedure according to the instructions provided by the manufacturer of the
interventional device. After completing the procedure, remove the guide extension catheter before removing
the guide catheter from the vessel.
8. Dispose of the guide extension catheter following standard hospital procedures.
9 Storage and handling
Store in a cool, dry, and dark place.
10 Disclaimer of warranty
The warnings contained in the product labeling provide more detailed information and are considered
an integral part of this disclaimer of warranty. Although the product has been manufactured under
carefully controlled conditions, Medtronic has no control over the conditions under which this product
is used. Medtronic, therefore, disclaims all warranties, both express and implied, with respect to the
product, including, but not limited to, any implied warranty of merchantability or fitness for a particular
purpose. Medtronic shall not be liable to any person or entity for any medical expenses or any direct,
incidental, or consequential damages caused by any use, defect, failure, or malfunction of the product,
whether a claim for such damages is based upon warranty, contract, tort, or otherwise. No person has
any authority to bind Medtronic to any representation or warranty with respect to the product.
The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene
mandatory provisions of applicable law. If any part or term of this disclaimer of warranty is held to be illegal,
unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining
portions of this disclaimer of warranty shall not be affected, and all rights and obligations shall be construed and
enforced as if this disclaimer of warranty did not contain the particular part or term held to be invalid.
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