Contraindications - Stryker Excelsior SL-10 Mode D'emploi

Excelsior SL-10
®
Excelsior 1018
®
p r e - s h a p e d
Microcatheter
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 Stryker Neurovascular representative.
For single patient 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.
For use with the following products:
• Excelsior SL-10 Pre-Shaped Microcatheter
• Excelsior 1018 Pre-Shaped Microcatheter
DevICe DesCrIptIon
Stryker Neurovascular Excelsior SL-10 Pre-Shaped Microcatheter and Excelsior 1018 Pre-Shaped Microcatheter are single lumen
devices designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire.
Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over
selectively placed guidewires. The Excelsior SL-10 Pre-Shaped and Excelsior 1018 Pre-Shaped Microcatheters have a distal shaft
length of 6 cm. Each microcatheter is 150 cm long. A luer fitting located on the microcatheter hub is used for the attachment of
accessories. Two radiopaque markers are positioned at the distal tip of the device to aid visualization under fluoroscopy. Stryker
Neurovascular Pre-Shaped Microcatheters are hydrophilically coated on the outer surface with Hydrolene® Coating that reduces
friction during manipulation in the vessel.
Stryker Neurovascular Excelsior SL-10 Pre-Shaped and Excelsior 1018 Pre-Shaped Microcatheters have pre-shaped distal tips,
available in 45, 90, J, C, and S shapes. The microcatheter tip, proximal to the pre-shaped portion, may be customized by steam
shaping. A shaping mandrel, steam shaping instruction card and peel away introducer are included within a separate inner
Tyvek® pouch.
Contents
One (1) Pre-Shaped Microcatheter
One (1) Packaging Mandrel
One (1) Steam Shaping Mandrel
One (1) Peel Away Introducer
One (1) Steam Shaping Instruction Card
table 1. Compatibility Information
Microcatheter Model Guide Catheter ID
Maximum Infusion pressure 2,070 kpa (300 psi)
excelsior sL-10 pre-shaped 1.00 mm (0.038 in)
excelsior 1018 pre-shaped 1.00 mm (0.038 in)
IntenDeD Use/InDICatIons For Use
Stryker Neurovascular Excelsior SL-10 Pre-Shaped Microcatheter and Excelsior 1018 Pre-Shaped Microcatheter are intended
to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils to the
peripheral, coronary, and neuro vasculature.

ContraInDICatIons

None Known.
warnInGs
these devices are intended for use only by physicians trained in performing endovascular procedures.
• The accessories are not intended for use inside the human body.
• Limited testing has been performed with solutions such as contrast media, saline and suspended embolic particles. The
use of these microcatheters for delivery of solutions other than the types that have been tested for compatibility is not
recommended. Do not use with glue or glue mixtures.
®
®
Max. Guidewire Dia. occlusion Coil Dia.
0.36 mm (0.014 in) 0.24 – 0.37 mm (0.0095 in – 0.0145 in)
0.41 mm (0.016 in) 0.24 – 0.38 mm (0.0095 in – 0.015 in)
• Carefully inspect all devices prior to use. Verify shape, size and condition are suitable for the specific procedure.
• Exchange microcatheters frequently during lengthy procedures that require extensive guidewire manipulation or multiple
guidewire exchanges.
• Never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by
fluoroscopy. Movement of the microcatheter or guidewire against resistance could dislodge a clot, perforate a vessel wall, or
damage microcatheter and guidewire. In severe cases, tip separation of the microcatheter or guidewire may occur.
CaUtIons
• Exercise care in handling of the microcatheter during a procedure to reduce the possibility of accidental breakage,
bending or kinking.
• To reduce the probability of coating damage in tortuous vasculature, use a guide catheter with a minimum internal diameter
that is ≥ 1.00 mm (0.038 in) and is recommended for use with Stryker Neurovascular hydrophilically coated microcatheters.
• To control the proper introduction, movement, positioning and removal of the microcatheter within the vascular system,
users should employ standard clinical angiographic and fluoroscopic practices and techniques throughout the interventional
procedure.
aDverse events
Please notify your Stryker Neurovascular representative immediately by telephone or FAX if a device malfunctions or patient
complication or injury is experienced or suspected associated with the use of this device. Please make every attempt to retain any
suspect device, its associated components and their packaging for return to Stryker Neurovascular.
Potential adverse events associated with the use of microcatheters or with the endovascular procedures include, but are not
limited to:
• Access site complications
• Allergic reaction
• Aneurysm perforation
• Aneurysm rupture
• Death
• Embolism (air, foreign body, plaque, thrombus)
• Hematoma
• Hemorrhage
• Infection
• Ischemia
• Neurological deficits
• Pseudoaneurysm
• Stroke
• Transient Ischemic Attack
• Vessel dissection
• Vessel occlusion
• Vessel perforation
• Vessel rupture
• Vessel thrombosis
• Vasospasm
how sUppLIeD
Stryker Neurovascular products are sterile and non-pyrogenic in unopened packaging that is designed to maintain sterility unless
the primary product pouch has been opened or damaged.
Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.
handling & storage
Store in a cool, dry, dark place.
operatIonaL InstrUCtIons
preparations for Use
warning: Inspect product before use for any bends, kinks or damage. Do not use a microcatheter that has been damaged.
Damaged microcatheters may rupture causing vessel trauma or tip detachment during steering maneuvers.
Caution: Flush dispenser coil of hydrophilically coated microcatheters prior to removal from dispenser coil. Once the
microcatheter has been wetted, do not allow to dry. Do not reinsert the microcatheter into dispenser coil.
1. Using the packaging tray, wet the hydrophilic outer shaft of the microcatheter.
. Remove packaging mandrel from microcatheter tip and discard. If desired, a secondary shape proximal to the pre-shaped tip
may be formed by following the secondary shaping instructions provided.
Caution: The packaging mandrel is not intended for reuse. The packaging mandrel is not intended for use inside the
human body.
3. Connect syringe filled with heparinized normal saline to microcatheter hub and flush microcatheter lumen to facilitate
guidewire insertion.
4. Carefully remove guidewire from its packaging and prepare the guidewire according to manufacturer's instructions.
5. Carefully insert guidewire into microcatheter hub either directly or via guidewire introducer. Advance guidewire into
microcatheter lumen until guidewire extends from distal microcatheter tip. If guidewire introducer is used, remove introducer
by withdrawing over guidewire.