Handling And Storage; Operational Instructions - Stryker Excelsior XT-27 Gebrauchsanweisung

• 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.
• 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
adverse Event reporting
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 anD STOraGE

Store in a cool, dry, dark place.

OPEraTIOnaL InSTrUCTIOnS

required additional Items
• Two 3 cm (3 cc) syringes and saline flush bags
3
• Continuous flush setup with two rotating hemostatic valves (RHVs) (Tuohy-Borst type)
• 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 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. Gently remove the microcatheter from the dispenser coil and inspect the microcatheter prior to use to
verify that it is undamaged.
2. If steam shaping is desired, refer to the Steam Shaping Instructions for Use section.
3. Connect flush-filled syringe to microcatheter hub and flush microcatheter lumen to facilitate
guidewire insertion.
Continuous Flush
The recommended continuous flush set up is illustrated in Figure 1. The RHVs provide a fluid tight seal and are
attached to the guide catheter and microcatheter. Attach the stopcocks to the RHV sidearms, which become
infusion ports for appropriate flush or contrast media injection.
Caution: Check that all fittings are secure so that air is not introduced into guide catheter or microcatheter
during continuous flush.
Caution: In order to achieve optimal performance of Stryker Neurovascular Microcatheters and to maintain the
lubricity of the Hydrolene® Coating surface, it is critical that a continuous flow of appropriate flush solution be
maintained between the Stryker Neurovascular Microcatheter and guide catheter, and the microcatheter and
any intraluminal device. In addition, flushing aids in preventing contrast crystal formation and/or clotting on
both the intraluminal device and inside the guide catheter and/or the microcatheter lumen.
Stopcock
Line to flush solution
40 kPa (300 mm Hg)
First RHV
Guide
Catheter
Steerable Guidewire
Microcatheter
Radiopaque
Tip Marker
Figure 1. Example of Continuous Flush Setup
4. 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.
5. Set up continuous flush by connecting first RHV to guide catheter and second RHV to hub of
microcatheter.
6. Carefully remove guidewire from its packaging and prepare the guidewire according to manufacturer's
instructions.
7. Carefully insert guidewire into microcatheter hub either directly or via guidewire introducer. Advance
through microcatheter lumen until guidewire extends from distal microcatheter tip. If guidewire
introducer is used, remove according to manufacturer's instructions.
8. Slide torque device over proximal end of guidewire per Figure 1, and secure.
Steam Shaping
Stryker Neurovascular Excelsior® XT-27™ Microcatheter is packaged with a steam shaping mandrel for
use when the physician desires to shape the distal tip.
warning: Shaping mandrel is not intended for use inside the human body.
To maintain the integrity of the inner diameter of the microcatheter, it is recommended that the steam shaping
instructions be strictly followed.
1. Remove shaping mandrel from packaging and insert the mandrel's entire working length into the
microcatheter's distal lumen.
2. Flush or dip microcatheter tip into heparinized saline to aid mandrel movement, bend the working length
of the shaping mandrel to desired microcatheter shape.
3. Shape microcatheter by holding mandrel/microcatheter assembly no closer than 2.54 cm (1 in) from
steam source for approximately 10 seconds.
Caution: Do not position microcatheter tip closer than 2.54 cm (1 in) from the steam source. Damage to
the microcatheter tip may result.
4. Remove mandrel from microcatheter and discard. Multiple shaping is not recommended.
3
3 cm 3 (3 cc) Syringe
Torque Device
Second RHV
Microcatheter
Stopcock
Hub
3 cm 3 (3 cc) Syringe
Line to flush solution
40 kPa (300 mm Hg)
Black (K) ∆E ≤5.0