Indications

The Teleport^‡ microcatheters are indicated for:

• supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature.
• exchanging guidewires in the coronary and peripheral vasculature.
• the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.
   

Contraindications

The use of the Teleport^‡ microcatheters are contraindicated:

• for use in patients with an unprotected left main coronary artery.
• for use in patients with arterial spasm in the absence of significant stenosis.
• for use in the neurovasculature.
   

Warnings

When using this type of device, the following warnings should be observed:

• This device is intended for single use only. Do not resterilize and/or reuse, as this can potentially result in compromised device performance and increased risk of cross­contamination.
• Do not modify this product for any reason. Modification of this product may compromise the integrity and performance of the product. Use of a modified product may result in vascular injury.
• The patient may suffer from subacute thrombosis, vascular complications, or bleeding complications by using this microcatheter. Therefore, it should be well examined if the intervention procedure will be applicable for the patient.
• The device must always be operated under high-resolution fluoroscopic guidance. Particular attention should be paid when inserting or withdrawing the device into stenotic areas, highly calcified lesions, stent struts, and narrower vessels than the product. Abrasion may result in damage or rupture of the device and the hydrophilic coating which may cause vascular injury, perforation, or distal emboli.
• If abnormal resistance is detected during use of this product, do not continue the operation, avoid excessive manipulations, and carefully remove the entire catheter system while paying full attention to avoid complications. Continuing the operation while the cause of the problem is not identified may cause damage to, or rupture of, the catheter, and damage the blood vessel.
• This microcatheter is coated with hydrophilic coating. Therefore, the microcatheter is highly lubricious. Always confirm the position of the distal end of the microcatheter by fluoroscopy and manipulate the microcatheter carefully.
• Do not insert the guidewire by force or advance it rapidly when the microcatheter is bent or twisted. Such manipulations may cause rupture or damage of the microcatheter, or perforation of the blood vessel.
• Always advance the guidewire ahead of the microcatheter before attempting any manipulation of the microcatheter. If the guidewire is not advanced ahead of the microcatheter, the blood vessel may be damaged or perforated, or the microcatheter may be damaged.
• Always hold the proximal hub with one hand and turn the catheter carefully while regularly releasing the accumulated torsion of the catheter. Never turn the catheter continuously while holding the proximal hub with both hands or use any other means to apply force. When releasing the accumulated torsion, be sure to open the hemostatic valve on the Y-connector. Do not turn the catheter in the same direction, either clockwise or counterclockwise, for more than 20 consecutive turns. If resistance is felt while turning the catheter, do not proceed with further rotation even if the 20-turn limit has not been reached. Identify the cause of resistance under fluoroscopy, and take appropriate action. Never continue the operation without identifying the cause; continuing rotation may damage or rupture the catheter or damage the blood vessel.
• When infusing contrast media, the device must be operated under high-resolution fluoroscopic guidance, confirming that the contrast media is being infused from the tip of the device. If the contrast media is not being infused, infusion must be stopped and the device must be replaced. If the device lumen is occluded, the device may be dilated, damaged, or ruptured, resulting in a life-threatening adverse event due to spurting contrast media.
• Injection pressure must not exceed 300 psi (the maximum injection pressure) when injecting contrast media using a power injector. Exceeding the maximum injection pressure may cause damage to the microcatheter.
• Discontinue injection if irregular resistance is felt at the syringe. The microcatheter may be bent or blocked. Excessive pressure may cause expansion and/or rupture of the microcatheter.
• Do not use a power injector to infuse contrast media when the microcatheter is bent or occluded. It may cause damage to the microcatheter such as expansion or breakage.
• Do not use guidewires larger than the recommended size. Resistance may be felt while advancing or withdrawing a guidewire larger than the recommended size, which may cause the catheter to become damaged or break, or the blood vessel to become damaged.
• If the device is inserted into vessels and the guidewire is to be replaced, insert the guidewire carefully. If any resistance is encountered, the operation must be discontinued immediately, and the device and the guidewire(s) withdrawn together. The device may be damaged and the tip may be cut.
• Do not wipe the surface of the microcatheter with gauze or absorbent cotton soaked with alcohols, gluconic acid chlorhexidine aqueous solution, or similar solutions as it may significantly deteriorate the lubricity of the microcatheter.
• Repeated insertion and withdrawal of the device may lead to deterioration of the hydrophilic coating. Continuous use of the device with deteriorated hydrophilic coating may cause vascular damage. This may also increase the risk of the tip being trapped, damaged, or ruptured.
   

Precautions

• Use the microcatheter prior to the "Use By" date specified on the package.
• Prior to use, the catheter should be examined to verify functionality and ensure that its size and length are suitable for the specific procedure for which it is to be used. Check to ensure that the microcatheter was not damaged during transportation. Do not use if the package and/or the product is suspected to be damaged.
• This product must be used under fluoroscopy by a physician who is fully trained in interventional procedures.
• Check the patient condition before the procedure. Provide appropriate anticoagulant therapy if necessary.
• When inserting the guidewire into the microcatheter that is already placed in the blood vessel, carefully operate the guidewire not to damage the microcatheter at the bend sections.
• When using a guiding catheter fitted with a stopcock, do not manipulate the stopcock after inserting the microcatheter into the guiding catheter. The microcatheter may be damaged if the stopcock is manipulated during the insertion.
• Operate the microcatheter carefully to avoid damage, kinks, or bends, especially when inserting into the guiding catheter.
• Flush the surface and the lumen of the microcatheter continuously with sterile heparinized saline during its use to maintain lubricity.
• When inserting or exchanging the microcatheter, flush the lumen of the guiding catheter and the microcatheter system continuously with sterile heparinized saline.
• This product is not intended for drug infusion other than contrast media. This product has not been designed for drug infusion other than contrast media and its safety has not been established for this indication.
• When infusing contrast media, read the Instructions for Use provided with such contrast media and comply with instructions, precautions, and warnings.
• Use the extension tube when contrast media is injected by using power injector.
• Confirm that the inserted microcatheter does not have a kink, knot, torsion, or occlusion before injecting contrast media.
• Flush the lumen of the microcatheter sufficiently with sterile heparinized saline especially after injecting contrast media.
• Discard all disposable devices used during this procedure per local requirements for medical device waste disposal.
   

Adverse Effects

Adverse events due to the use of this product include, but are not limited to, the following:

• Acute myocardial infarction
• Acute, or subacute, thrombosis
• Acute vessel closure
• Allergic reaction to device, contrast medium, or medication
• Aneurysm
• Arrhythmias
• Arteriovenous fistula
• Death
• Dissection (perforation, rupture, or injury) of the vessel
• Distal emboli
• Hemorrhage or hematoma
• Hypertension
• Hypotension
• Infection
• Ischemia
• Stroke by air embolism or embolization of fragments of thrombotic or atherosclerotic material
• Total occlusion of the artery resulting in ischemia
• Vascular spasm

CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available), at manuals.eifu.abbott or at eifu.orbusneich.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. This material is intended for use with healthcare professionals only.