Indications, Safety, and Warnings Telescope™ Guide Extension Catheter

Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warning and precautions.

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.

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

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.

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.
  • 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.

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.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

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