OptiSeal

OptiSeal Valved
PTFE Peelable Introducer
Instructions for Use
Device Description
The OptiSeal Valved PTFE Peelable Introducer
is designed to reduce blood loss and air intake by
providing hemostatic sealing at venous pressures.
The device is offered in two configurations, one
without a sideport and one with a sideport attached
to a segment of extension tubing terminating in a
3-way stopcock.
Intended Use
The OptiSeal Valved PTFE Peelable Introducer
is intended for use in the percutaneous insertion of
pacing leads or catheters in the venous system.
Sterile Kit Contents
• 1 Introducer (with or without sideport)
• 1 Guidewire (.035”/.89mm)
• 1 Needle (18 gauge)
• 1 Syringe (12cc)
Contraindications
Use of this product is contraindicated if the patient
has a known or suspected obstruction in the
intended access vein. There is increased risk of
pneumothorax for the patient who has severe
chronic lung disease. Poor healing may result in
the patient who has had irradiation to the anterior
chest.
Precautions
• Store in dry, dark, cool place.
• Do not use if package is opened or damaged.
• Inspect all components prior to use.
• Product was sterilized using Ethylene Oxide.
• The introducer shall be used only with
components contained in this kit and is
intended for use with leads or catheters with
the same or smaller diameter than the inner
diameter stated on the label.
Cautions
• Product may only be used by medically
skilled personnel thoroughly trained in this
procedure.
• Product not intended for arterial use as a
hemostatic device. Insertion into an artery
may cause excessive bleeding and/or other
complications.
• Only use the sideport to inject or aspirate
through the sheath.
2
• The product is intended for use with leads
and catheters with a smaller diameter than
the inner diameter of the sheath.
• Dilators, leads, and catheters should be
removed slowly from the product. Rapid
removal may damage the valve members
resulting in blood flow through the valve.
• Do not attempt to use a guidewire over the
maximum diameter of .038 inches or
.965 millimeters.
• Do not over torque the dilator nut.
• If resistance is met when advancing or
withdrawing the guidewire or the introducer,
determine the cause by fluoroscopy and
correct before continuing with the procedure.
• Do not use forceps to break the handle
and/or to peel the sheath.
• Apply symmetrical force while peeling the
sheath.
• Individual patient anatomy and physician
technique may require procedural variations.
• Federal (USA) law restricts this device to sale
by or on the order of a physician.
Warnings
• Do not alter this product in any way.
• Do not use alcohol, acetone or solutions
containing these agents. These solutions
may affect the properties of the plastic
components resulting in degradation of the
product and compromised performance.
• Ensure all air is removed from the product
prior to infusing through the sideport.
• Do not aspirate through the sideport while
the guidewire is positioned in the valve of
the sheath.
• Aspiration with the guidewire through the
valve may cause an air embolism.
• Do not withdraw guidewire through metal
needles; guidewire may shear or unravel.
• For single use only. DO NOT REUSE,
DO NOT RESTERILIZE.
• Reuse of single-use devices creates a
potential risk of patient or user infections.
• Contamination of the device may lead
to injury, illness or death of the patient.
Cleaning, disinfection and sterilization may
compromise essential material and design
characteristics leading to device failure.
Potential Complications
The potential complications related to the use
of the product include, but are not limited to the
following:
• Air Embolism
• Artery puncture
• Pneumothorax
• Hemothorax
• Hematoma formation
• Brachial plexus injury
• Vein thrombosis