Instructions For Use - Seigla LiquID 061 6F Instrucciones De Uso

Guide Catheter Extension
DEVICE DESCRIPTION
The LiquID Guide Catheter Extension is a single lumen
catheter offered in a 6F and 7F size. The 150cm device has a
stainless-steel shaft connected to a 15cm single lumen tube,
which is used to extend traditional guide catheters. The 15cm
single lumen tube catheter body contains a coil for kink
resistance and radiopacity. The single lumen tube catheter
body is also silicone coated for lubricity. The device has two
proximal positioning marks located at 95cm and 105cm from
the distal tip. The device handle is color coded to match the
standard guide catheter color code.
DEVICE COMPATIBILITY
MODEL SIZE ID
LiquID 061 0.061 inches
6F (1.55mm)
LiquID 071 0.071 inches
7F (1.80mm)
INTENDED USE
The LiquID Guide Catheter Extension 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 2.5mm in diameter
• Vessels in the neurovascular system and the
venous system
WARNINGS
• Do not use the device if the sterile barrier has been
damaged. Use of a non-sterile device may cause infection.
• For single use only. Do not reuse, reprocess, or re-sterilize
the device. Reuse, reprocessing, or re-sterilization
may compromise device integrity resulting in device
separation or vessel injury. Reuse may also cause device
contamination which may result in infection.
• Use prior to the "use by" date as indicated on the label
• Never advance the LiquID device into a vessel without a
leading guidewire or without confirming location using
fluoroscopic guidance. Vessel injury may result.
• Never advance the LiquID device into a vessel with
an effective diameter less than 2.5mm. Vessel injury,
ischemia, and/or occlusion may result. If pressure in
a vessel dampens after inserting the LiquID device,
withdraw the LiquID device immediately.
• Never advance the LiquID device more than 10cm
beyond the guide catheter tip. The LiquID device may
become lodged in the guide catheter making it difficult
to remove.
• Never advance or withdraw an intravascular device against
resistance until the cause of resistance is determined
by fluoroscopy. Movement of the catheter or guidewire
against resistance may result in separation of the catheter
or guidewire, catheter damage, or vessel injury.
COMPATIBLE GUIDE
OD
CATHETER
0.068 inches
≥6F
(1.73mm)
0.078 inches
≥7F
(1.98mm)
PRECAUTIONS
• This device should be used only by physicians trained in
percutaneous, intravascular techniques and procedures.
• Inspect the device prior to use for any bends or kinks. Use
of a damaged device may result in device separation or
vessel injury.
• Flush the device lumen with heparinized saline prior to use.
• Use of systemic anti-coagulation therapy should be
considered to prevent or reduce clotting when any device
is used in the vascular system.
• Handle the device with care during the procedure to
prevent the possibility of accidental breakage, bending,
or kinking.
• This device should not be torqued. Torqueing the device
may result in device entrapment or vessel injury.
• Manipulate the device only under fluoroscopy when in
the body to reduce the risk of vessel injury.
ADVERSE EVENTS
The adverse events include, but are not limited to:
• Allergic reaction
• Arterial spasm
• Embolism
• Hemorrhage/hematoma
• Infection
• Ischemia
• Myocardial infarction
• Occlusion
• Thrombus
• Vessel injury (i.e. perforation, dissection,
intimal disruption)
HOW SUPPLIED
The LiquID device is supplied STERILE using an ethylene oxide
(EO) process. Do not use if the sterile barrier is damaged.
Packaging is designed to maintain sterility according to labeled
"use by" date. Do not use if labeling is incomplete or illegible.
ANCILLARY DEVICES
• Guide catheter
• Y-adaptor with hemostasis valve
• Guidewire
• 10cc sterile syringe for flushing
• Sterile heparinized saline
DEVICE OPERATION
Preparations for Use
1. Inspect the LiquID device sterile barrier for damage.
2. Transfer the dispenser coil with the LiquID device into the
sterile field using standard sterile handling procedures.
3. Remove the LiquID device from the dispenser coil.
4. Flush the LiquID device lumen with heparinized sterile
saline using a 10cc syringe via the distal tip.

Instructions for Use

1. Inspect the LiquID device prior to use to verify that it has
not been damaged during handling.
2. Backload the LiquID device onto the guidewire
and advance until the catheter is proximal of the
hemostasis valve.
3. Open the hemostasis valve and advance the LiquID
device into the guide catheter.
4. Advance the LiquID device through the guide catheter
and into the desired vessel position.
2