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Excelsior
SL-10
®
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.
DEVICE DESCrIPTIOn
Stryker Neurovascular Excelsior SL-10 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. A luer fitting located on the microcatheter hub is used for the attachment of
accessories. A radiopaque tip facilitates fluoroscopic visualization.
Stryker Neurovascular Excelsior SL-10 Microcatheter is coated on the outer surface with Hydrolene® Coating
that reduces friction during manipulation in the vessel.
Microcatheters are packaged with a steam shaping mandrel accessory.
Table 1. Compatibility Information
Refer to the corresponding Stryker Neurovascular Directions for Use for information regarding microcatheter
compatibility.
Microcatheter
Shaft Length (cm)
Excelsior SL-10
150
InTEnDED USE/InDICaTIOnS fOr USE
Stryker Neurovascular Excelsior SL-10 Microcatheter is intended to assist in the delivery of diagnostic agents,
such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and
neurovasculature.
COnTraInDICaTIOnS
None Known
warnInGS
These devices are intended for use only by physicians trained in performing endovascular procedures.
•
Limited testing has been performed with solutions such as contrast media, saline and suspended
embolic particles. The use of these catheters 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.
•
The accessories are not intended for use inside the human body.
•
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.
®
Guidewire Dia.
Guide Catheter ID mm (in)
mm (in)
1.00 mm (0.038 in)
0.36 mm (0.014 in)
CaUTIOnS
•
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.
•
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
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
adverse Event reporting
Please notify your Stryker Neurovascular representative immediately by telephone or FAX 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 and 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. Connect flush-filled syringe to microcatheter hub and flush microcatheter lumen to facilitate guidewire
insertion.
. Carefully remove guidewire from its packaging and prepare the guidewire according to manufacturer's
instructions.
3. Carefully insert guidewire into microcatheter hub either directly or via guidewire introducer. Advance to
microcatheter lumen. If guidewire introducer is used, remove introducer by withdrawing over guidewire.
4. Slip torque device over proximal end of guidewire per Figure 1, and secure.
5. Attach stopcocks to sidearm of both RHVs.
6. Connect both RHVs to flush solution pressure bag. Pressure packs are convenient for this purpose.
Maintain pressure above arterial pressure (approximately 40 kPa (300 mm/Hg)) in order to prevent
retrograde flow of blood into guide catheter or microcatheter.
7. Set up continuous flush by connecting First RHV to hub of microcatheter and Second RHV to guide catheter.
•
Neurological deficits
•
Pseudoaneurysm
•
Stroke
•
Transient Ischemic Attack
•
Vessel dissection
•
Vessel occlusion
•
Vessel perforation
•
Vessel rupture
•
Vessel thrombosis
•
Vasospasm
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