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GUIDEZILLA™ II Guide Extension Catheter Indications

Indications, Safety, and Warnings

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CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

The GUIDEZILLA II 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

  • Vessels less than 2.5 mm in diameter.
  • Vessels in the neurovasculature and the venous system.

WARNINGS

  • Never advance the GUIDEZILLA II Catheter into a vessel without a leading guidewire or without confirming location using fluoroscopic guidance. Vessel dissection or perforation may result.
  • Due to the size and non-tapered tip of the GUIDEZILLA II Catheter, extreme care must be taken to avoid vessel ischemia or vascular damage.
  • This is a non-torqueable device. Torqueing the device may result in wire wrap or damage to the device or vessel.
  • Never advance the GUIDEZILLA II Catheter into a vessel with an effective diameter less than 2.5 mm. Vessel injury, ischemia, and/or occlusion may result. If pressure in a vessel dampens after inserting the GUIDEZILLA II Catheter, withdraw the GUIDEZILLA II Catheter until the pressure returns to normal.

Precautions

  • The device lumen should be thoroughly flushed with heparinized saline prior to use.
  • This device should be used only by physicians thoroughly trained in percutaneous, intravascular techniques and procedures.
  • Exercise care in handling of the device during a procedure to reduce the possibility of accidental breakage, bending or kinking.
  • Never advance the GUIDEZILLA II Catheter more than 15 cm beyond the tip of the guide catheter. Further distal advancement of the GUIDEZILLA II Catheter could cause the entire guide segment to track outside of the guide catheter
  • and impede withdrawal of the device.
  • 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 devices simultaneously. 

ADVERSE EVENTS

The adverse events include, but are not limited to:

  • Allergic reaction
  • Arterial spasm
  • Death
  • Embolism
  • Hemorrhage/hematoma (e.g., vascular access complication)
  • Infection
  • Intimal disruption
  • Myocardial infarction
  • Renal failure
  • Slow-flow/occlusion
  • Thrombus
  • Vascular complication (e.g., puncture site complication)
  • Vessel trauma
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