INDICATIONS, SAFETY, AND WARNINGS Piton GC Carotid Guide Catheter

Note: Please refer to your region’s Instructions for Use for specific details.

This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call Medtronic at +1 763-514-4000 (Worldwide). Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions. 

INDICATIONS

The Piton™ GC Carotid Guide Catheter is intended to facilitate the introduction and placement of interventional devices (e.g., guidewires, stent delivery systems, dilation balloons, angiographic- or micro-catheters, etc.) into the human vasculature to treat vascular obstructive disease, including but not limited to the supraaortic vessels.

CONTRAINDICATIONS

There are no known contraindications for this device.

WARNINGS

  • This device is designed and intended for single use only. DO NOT RESTERILIZE AND/OR REUSE. Reuse or resterilization may create a risk of contamination of the device and/or cause patient infection or cross-infection, including (but not limited to) the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. Reuse or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness and death. INVATEC will not be responsible for any direct, incidental or consequential damages resulting from resterilization or reuse.
  • Inspect the device, prior to procedure, to verify functionality and lack of damaged parts. Do not use the device if the outer or the inner package is damaged or opened.
  • Do not expose the device to organic solvents, e.g. alcohol.
  • When the guide catheter is in the body, it should be manipulated while under sufficient and/or high quality fluoroscopy. Do not attempt to advance the catheter without paying careful visual attention to the tip response.
  • Only physicians thoroughly trained and educated in the performance of transluminal angioplasties should use this device. Physicians should keep themselves informed and updated on recent publications about transluminal angioplasty techniques.
  • Do not use with Lipiodol contrast media, or other such contrast media, which incorporate the components of these agents.
  • If resistance is felt during insertion and/or manipulation of the device, determine the cause of resistance under fluoroscopy and take immediate remedial action.
  • If the guide catheter is moved excessively, it may be damaged or may dislodge debris or emboli from the vessel wall, which can result in embolization of distal vessels.
  • When torquing the guide catheter inside the vessel, do not exceed two rotations (720°) in the same direction without movement of the tip. This may damage the guide catheter or separate the tip, resulting in vessel injury or fragments might embolize distal vessels.
  • Use the device prior to the “Use By” date specified on the package.

PRECAUTIONS

  • Use prior to “Use By” date.
  • Appropriate drug therapy (anticoagulant, vasodilator, etc.) should be administered to the patient according to standard protocols for percutaneous transluminal angioplasty.
  • Exercise care during handling in order to avoid possible damage to the guide catheter. Avoid acute bending or kinking of the guide catheter itself. Do not use a guide catheter that has been damaged. Do not attempt to straighten a guide catheter that has been kinked or bent. Do not advance any device through a kinked guide catheter to reduce the potential of entrapment or device damage.
  • Keep at controlled room temperature, in a dry place. Keep away from sunlight.
  • Should any resistance be felt at any time during manipulation, insertion or withdrawal of the guide catheter, do not force or continue: stop the procedure immediately and determine the cause of the resistance before proceeding. Excessive force against resistance may result in damage of the device or the vessels.
  • Various devices and catheters are designed to be compatible with different size guide catheters. Carefully check and match the device compatibility to the proper inner diameter of the guide catheter prior to use.
  • Only interventionalists who have sufficient experience should carry out transluminal angioplasty. A thorough understanding of the technical principles, clinical applications and risks associated with transluminal angioplasty is necessary before using this device.
  • Allergic reactions to contrast medium should be identified before treatment.
  • Check that the catheter size is compatible with the interventional devices (e.g. guidewires, stent delivery systems, dilation balloons, angiographic- or micro-catheters, etc.) for the procedure which are intended to be used in.

POTENTIAL COMPLICATIONS / ADVERSE EFFECTS

Complications associated with the use of a Piton™ GC Carotid Guide Catheter are similar to the ones associated with standard PTA procedures. Possible complications may include, but are not limited to:

  • Death
  • Stroke
  • Vascular spasm
  • Vessel dissections, perforation, rupture
  • Hypo-/hypertension
  • Sepsis/infection
  • Arrhythmia, including ventricular fibrillation
  • Hemorrhage or hematoma
  • Arteriovenous fistula
  • Pseudo-aneurysm
  • Thrombosis and/or embolization