Stryker Excelsior SL-10 PRE-SHARED - Page 2

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Stryker Neurovascular (DFU Template 8in x 8in Global), DFU, Excelsior SL-10, Global, NV00020540-01A
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.
DEVICE DESCRIPTION
Stryker Neurovascular Excelsior SL-10 Pre-Shaped Microcatheters 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 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 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 the tray.
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 Max. Guidewire Dia. Occlusion Coil Dia.
Maximum Infusion Pressure 2,070 kPa (300 psi)
Excelsior SL-10 Pre-Shaped 1.00 mm (0.038 in) 0.36 mm (0.014 in) 0.24 – 0.37 mm (0.0095 in – 0.0145 in)
INTENDED USE/INDICATIONS FOR USE
Stryker Neurovascular Excelsior SL-10 Pre-Shaped Microcatheters 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.
• 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.
• To facilitate microcatheter handling, the proximal portion of the microcatheter does not have the hydrophilic surface. Greater
resistance may be encountered when this section of the microcatheter is advanced into the RHV.
• Limited testing indicates that Excelsior SL-10 Pre-Shaped Microcatheter is compatible with Dimethyl Sulfoxide (DMSO).
The compatibility of Excelsior SL-10 Pre-Shaped Microcatheter with individual agents suspended in DMSO has not been
established.
• Use the product prior to the “Use By” date printed on the label.
ADVERSE EVENTS
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
• Vasospasm
• Vesseldissection
• Vesselocclusion
• Vesselperforation
• Vesselrupture
• Vesselthrombosis
Please notify your Stryker Neurovascular representative immediately if a device malfunctions or patient complication or injury is
experienced or suspected. Please make every attempt to retain any suspect device, its associated components and their packaging
for return to Stryker Neurovascular.
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
Required additional items:
• Two3ccsyringes
• Continuousflush
• Twostopcocks
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 packaging tray of hydrophilically coated microcatheters prior to removal from packaging tray. Once the
microcatheter has been wetted, do not allow to dry. Do not reinsert the microcatheter into packaging tray.
1. Using the packaging tray, wet the hydrophilic outer shaft of the microcatheter.
2. 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.
Excelsior
®
SL-10
®
Microcatheter
pre-shaped