Input

Indications for Use

A percutaneous introducer is used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices.

Contraindications

Patient must not exceed a 60° angle position post-procedure (see diagram below). An introducer obturator must be inserted into the sheath before a patient can sit up. Excluded sizes from 60° sitting up, once the sheath/obturator has been inserted, are listed below.

Warnings

• For single patient use only. Do not reuse, reprocess or resterilize this product. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device which could result in patient injury, illness or death. Cleaning, disinfection and resterilization may compromise the essential material and design characteristics of the device leading to device failure.
• Pre-dilation may be required when introducing a sheath/dilator system through scar tissue.
• To introduce a balloon catheter via percutaneous introducer, consult the catheter manufacturer's directions for the recommended introducer size and compare the inside diameter of the sheath to the outside diameter of the balloon. In general, the introducer set chosen will be one or two French sizes larger than the French size of the balloon catheter.
• Introducers include a gasket seal assembly at the proximal end to minimize blood loss during introduction of a one size smaller intravascular device. Increased blood loss will result if this limit is exceeded.
• Introducers are designed to accept catheters which are either the same French size or one size smaller than the sheath. The user must select catheters which are labeled with the true French size. Use one French size larger introducers for catheters exceeding the labeled French size.
• A continuous drip under pressure is required through the side port when the introducer is left in the vessel. Aspiration is also recommended on withdrawal of the intravascular device or dilator to remove any fibrin deposition which may have accumulated in or on the tip of the sheath.
• Introducer sheaths and dilators should not be interchanged unless they are of the same catalog number.
• Except for the following noted excluded sizes, the introducer allows the patient to assume up to 60° angle position, with obturator inserted, post-procedure. (11 cm and 23 cm lengths, 4F, 10F, and 11F excluded; all French sizes for 7 cm length excluded.)
• In those cases where both an arterial and venous side sheath are used, both sheaths must support a patient sit-up claim.
• Do not withdraw the guide wire back into the cannula when using a metal cannula, because this may result in shearing of the guide wire. Remove the cannula first.
• Simultaneously advance the sheath and the dilator with a rotational motion to prevent sheath damage.
• When using a second introducer near another, use caution when inserting needle to prevent damaging the first introducer.
• Do not advance or withdraw the introducer and/or guide wire if resistance is met without first determining the cause.
• Percutaneous introducer sheaths should not remain indwelling without the internal support of a catheter, electrode, dilator, or obturator. If the patient is going to sit up, an obturator must be placed inside the introducer, and the patient should not sit up more than 60°. See "Contraindications" for sit up restrictions.
• Rapid withdrawal of the inner catheter may cause misalignment of the gasket assembly, resulting in blood flow through the gasket assembly. To correct, reinsert the catheter tip into the gasket assembly and tap lightly.
• Anaphylactic response to the coated introducer has been observed shortly after introduction of the device into the patient. Association of the response with the introducer was confirmed by dermal contact testing following the procedure. If an anaphylactic response occurs, the introducer should be removed and the appropriate anaphylaxis treatment initiated.

Precautions

• Due to the presence of DEHP in the sidearm tubing of this device, it is not recommended for use in minors and pregnant or nursing women.
• Percutaneous introducers should be used by or under the supervision of a physician trained in the techniques of vascular access and/or catheterizations.
• Inspect all components prior to use. If components are damaged, do not use.
• These introducers are supplied sterile and non-pyrogenic. Do not use if introducer package is opened or damaged.
• After use, this product may be a potential biohazard. Handle and dispose of all such devices in accordance with accepted medical practice and applicable local, state and federal laws and regulations.

CAUTION: Federal (U.S.A.) law restricts sale, distribution, and use by or on the order of a physician.