Telescope™
`Guide Extension Catheter
`
`Instructions for Use
`
`Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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`

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`The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners.
`Medtronic, Telescope
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`Figure 1. Distal guide segment
`
`EN
`
`1 Distal marker band
`2 Proximal marker band
`
`3 Entry port
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`3
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`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
`ISO 15223-1
`Clause 5.1.1
`ISO 15223-1
`Clause 5.2.8
`
`Symbol title
`Manufacturer
`
`Do not use if package is
`damaged
`
`Explanatory text
`Indicates the medical
`device manufacturer.
`Indicates a medical device
`that should not be used if
`the package has been
`damaged or opened.
`Indicates a medical device
`that is intended for one
`use, or for use on a single
`patient during a single pro-
`cedure.
`Indicates the minimum
`inner diameter of the guide
`catheter.
`Indicates the quantity of
`devices present in the
`package.
`Indicates the manufactur-
`er’s batch code so that the
`batch or lot can be identi-
`fied.
`Indicates the date after
`which the medical device
`is not to be used.
`Indicates the date when
`the medical device was
`manufactured.
`Indicates a medical device
`that has been sterilized
`using ethylene oxide.
`Indicates the manufactur-
`er’s catalogue number so
`that the medical device
`can be identified.
`To indicate a reference to
`the inner diameter
`To identify the location
`where the package can be
`opened and to indicate the
`method of opening it.
`Indicates the manufactur-
`ing site of the device. A
`manufacturing site is the
`facillity where the product
`is produced, transformed,
`or assembled into a medi-
`cal device.
`Indicates the adjacent
`text/symbology is intended
`for US audiences only.
`Indicates the need for the
`user to consult the instruc-
`tions for use.
`Indicates the need for the
`user to consult the instruc-
`tions for use.
`
`ISO 15223-1
`Clause 5.4.2
`
`Do not reuse
`
`N/A
`
`N/A
`
`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
`
`N/A
`
`ISO 15223-1
`Clause 5.4.3
`ISO 15223-1
`Clause 5.4.3
`
`Guide catheter/minimum
`inner diamter
`Quantity
`
`Lot Number
`
`Use by date
`
`Date of manufacture
`
`Sterlized using ethylene
`oxide
`Catalogue number
`
`Inner diameter
`
`Open here
`
`Manufactured in
`
`For US audiences only
`
`Consult instructions for
`use
`Consult instructions for
`use at this website
`
`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
`
`4
`
`Telescope distal guide
`segment length
`25 cm
`25 cm
`
`Compatible guide cath-
`eter
`6 Fr
`7 Fr
`
`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
`TELE7F
`7 Fr
`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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`Warning: Do not advance the guide extension catheter more than 15 cm beyond the tip of the guide catheter
`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.
`
`• 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.
`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.
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`4.
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`5
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`Page 7
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`Medtronic, Inc.
`710 Medtronic Parkway
`Minneapolis, MN 55432
`USA
`www.medtronic.com
`+763 514 4000
`LifeLine Technical Support, 24-hour consultation service:
`1 877 526 7890
`Customer service and product orders:
`1 888 283 7868
`
`© 2019 Medtronic
`M976778A001 1B
`2019-01-17
`
`*M976778A001*
`
`