Contraindications - Boston Scientific Guidezilla Ii Gebrauchsanweisung

Guidezilla
Guide Extension Catheter
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
WarnInG
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile
barrier is damaged. If damage is found, call your Boston Scientific representative.
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing
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 or death.
Reuse, reprocessing or resterilization may also 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.
After use, dispose of product and packaging in accordance with hospital,
administrative and/or local government policy.
DevICe DesCrIptIon
The Guidezilla II Guide Extension Catheter is a single-lumen rapid exchange
catheter designed to act as an extension to a traditional guide catheter and
facilitate the delivery of interventional devices into the vasculature. The 150 cm
device consists of a hydrophilic-coated, single-lumen distal guide segment
connected to a stainless steel proximal hypotube. The distal guide segment
contains a platinum-iridium radiopaque marker band located 2 mm from the distal
tip and a proximal platinum-iridium radiopaque collar. The proximal hypotube
contains two positioning marks located at 90 cm and 100 cm from the distal tip. A
tab on the proximal end of the hypotube is used for device identification.
table 1. Compatibility Information
Distal Guide
Model
segment Length
6F 25 cm
7F 25 cm
8F 25 cm
6F LONG 40 cm
Contents
Qty Material
One (1) Single-use Guidezilla II Guide Extension Catheter
Black (K) ∆E ≤5.0
II
™
Compatible Guidezilla II
Guide Catheter ID
≥ 6F / ≥ 0.070 in ID
0.057 in (1.45 mm)
(1.78 mm)
≥ 7F / ≥ 0.078 in ID
0.063 in (1.60 mm)
(1.98 mm)
≥ 8F / ≥ 0.088 in ID
0.072 in (1.83 mm)
(2.24 mm)
≥ 6F / ≥ 0.070 in ID
0.057 in (1.45 mm)
(1.78 mm)
IntenDeD Use/InDICatIons for Use
The Guidezilla II Guide Extension Catheter 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 2.5 mm in diameter.
• Vessels in the neurovasculature and the venous system.
WarnInGs
• Use prior to the "use by" date as indicated on the label.
• Never advance the Guidezilla II Catheter into a vessel without a leading
guidewire or without confirming location using fluoroscopic guidance. Vessel
dissection or perforation may result.
• Due to the size and non-tapered tip of the Guidezilla II Catheter, extreme care
must be taken to avoid vessel ischemia or vascular damage.
• Where there is limited clearance between interventional devices and the
distal guide segment lumen, those devices must be advanced and withdrawn
slowly with the hemostasis valve open to reduce the risk of embolism.
• This is a non-torqueable device. Torqueing the device may result in wire wrap
or damage to the device or vessel.
• Never advance the Guidezilla II Catheter into a vessel with an effective
diameter less than 2.5 mm. Vessel injury, ischemia, and/or occlusion may
result. If pressure in a vessel dampens after inserting the Guidezilla II Catheter,
withdraw the Guidezilla II Catheter until the pressure returns to normal.
preCaUtIons
• Inspect the device prior to use for any bends or kinks. Any device damage
may decrease the desired performance characteristics.
• The device lumen should be thoroughly flushed with heparinized saline prior
to use.
• This device should be used only by physicians thoroughly trained in
percutaneous, intravascular techniques and procedures.
• Precautions to prevent or reduce clotting should be taken when any catheter
is used in the vascular system. Use of systemic heparinization and heparinized
sterile solution should be considered.
• Exercise care in handling of the device during a procedure to reduce the
possibility of accidental breakage, bending or kinking.
• When the device is in the body, it should be manipulated only under
fluoroscopy. Do not attempt to move the device without observing the
resultant tip response.
• Never advance the Guidezilla II Catheter more than 15 cm beyond the tip of
the guide catheter. Further distal advancement of the Guidezilla II Catheter
could cause the entire guide segment to track outside of the guide catheter
and impede withdrawal of the device.
• If strong resistance is encountered during manipulation of the devices, do not
force passage. Determine the cause of the resistance before proceeding. If
the cause cannot be removed, withdraw all devices simultaneously.
2