Terumo Tercross Mode D'emploi page 7

INDICATIONS
The Tercross is intended to be used for percutaneous transluminal angioplasty (PTA). It is designed specifically to dilatate stenosis
of peripheral arteries, such as iliac, femoral, popliteal, infra-popliteal and renal artery other than cephalic, cervical and cardiac.
Do not use for other applications.
DESCRIPTION
Tercross is a PTA Dilatation catheter with a coaxial system. The tip of the catheter is equipped with a balloon inflatable to a specific
diameter and length at recommended pressures. One or two radiopaque markers inside the balloon allow for confirmation of the
balloon's position in the patient's vessel under fluoroscopy. At the proximal end, the catheter has a guide wire port, where a guide
wire is to be inserted, and a balloon inflation port used for inflation/deflation of the balloon. The inner lumen is used as a passage of
a guide wire, and the outer lumen is used for inflation/deflation of the balloon. The inner lumen cannot be used for angiography or
pressure monitoring because of the small diameter. The maximum size guide wire that may be used is 0.014 inches (0.36mm) in
diameter. The surface of catheter is partially coated with hydrophilic polymer coating which generates lubricity when wet.
CONTRAINDICATIONS
• Patients having a lesion that is uncrossable with a guide wire.
• Do not use this catheter in coronary and cerebral vessels.
COMPLICATIONS
Possible complications of PTA include, but are not limited to, the following:
•Infection and pain at the puncture side •Arrhythmias •Arteriovenous fistula •Vascular dissection, perforation, rupture or injury
•Vasospasm •Hypotension •Distal embolization air, device, plaque, etc. •Haematoma •Ischaemia •Haemorrhage •Death
•Restenosis •Allergic reaction to contrast medium •Sepsis •Pseudoaneurysm •Vessel thrombosis
WARNINGS /PRECAUTIONS
WARNINGS
• Advance the dilatation catheter carefully within the artery and, if any resistance is felt, stop manipulating the dilatation
catheter and determine the cause under fluoroscopy. Continuing to advance the dilatation catheter may result in
damage to the artery and/or separation or laceration of the dilatation catheter. This may necessitate recovery of
fragments of the dilatation catheter.
• Within the stent strut, advancement or removal or inflation of the dilatation catheter should be done carefully under
fluoroscopy. Failure to take care could result in vascular injury or damage/breakage of the dilatation catheter due to
stent abrasion, and the balloon bursting below the rated burst pressure.
• Do not reuse the balloon protective sheath mounted on the dilatation catheter once it has been removed. Failure to
observe this warning could cause the balloon not to inflate or deflate due to balloon deformation and damage of the
shaft.
• Make sure that the balloon is deflated completely when inserting into the introducer sheath, removing from the
introducer, advancing in the artery, and/or withdrawing from the artery. Manipulating the catheter without deflating the
balloon may result in damage to the artery and/or separation or laceration of the dilatation catheter.
PRECAUTIONS
• This product has been sterilized by ethylene oxide gas. For single use only. Do not reuse. Do not resterilize. Do not reprocess.
Reprocessing may compromise the sterility, biocompatibility and functional integrity of the device.
• Sterile and non-pyrogenic in an unopened and undamaged unit package. Do not use if the unit package or the product have been
damaged or soiled.
• The product should be used immediately after opening the package and be disposed of safely and properly after use.
• The dilatation catheter should be used by a physician who is familiar with, and well trained in, PTA techniques.
• Do not soak the dilatation catheter in sterilizing alcohol or drug solutions containing organic solvents, or wipe the catheter with
drugs. Failure to observe this precaution could damage or break the dilatation catheter or cause loss of lubricity.
• Any advancement after introduction of the dilatation catheter into the artery should be done under fluoroscopy.
• The entire operation should be carried out aseptically.
• Use an inflation/deflation device equipped with an accurate manometer. The balloon may rupture if over-inflation occurs due to
inaccurate determination of balloon pressure.
• Administer appropriate anticoagulant to the patient during the PTA procedure. Carry out appropriate anticoagulant therapy under
direction of the physician in charge after completion of the PTA procedure.
• Do not use agents containing organic solvents or oleaginous contrast media. Contact with these agents may lead to damage of
the dilatation catheter and/or rupture of the balloon.
• Always handle dilatation catheters with care, and avoid kinks. Do not use if kinked. A kink could damage or break the dilatation
catheter.
• Operate the dilatation catheter with utmost care while performing the kissing balloon technique or parallel wire technique, to avoid
entanglement with the accompanying device. If resistance is encountered, remove the dilatation catheter and the accompanying
device together.
• Choose the appropriate balloon size from the diagnostic site and anatomic aspect.
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ENGLISH
PTA Dilatation Catheter (OTW)