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FiberNet_CH.fm 3/29/12 01:17 pm
8.46 x 11.02 inches (215.0 mm x 280.0 mm)
Embolic Protection System
1.0 CONTENTS
The FiberNet Embolic Protection System consists of one capture wire, one
retrieval catheter, two 30-mL syringes, one extension line with one-way
stopcock, one actuator, one peel-away introducer, and one 40-µm filter basket.
The FiberNet Embolic Protection System does not contain natural rubber latex.
However, during the manufacturing, assembly, or packaging process, it may
have incidental contact with materials, tools, or equipment containing or coming
in contact with latex.
2.0 DEVICE DESCRIPTION
The FiberNet Embolic Protection System is an intravascular filtration system
that is placed distal to the lesion before interventional procedures. When
deployed, the system captures and recovers emboli that may be produced
during the procedure. The capture wire is used as a standard 0.36 mm (0.014 in)
steerable guidewire. Radiopaque markers at the distal tip of the wire and the
proximal end of the filter aid in placement and deployment visualization under
fluoroscopic imaging. The distal tip of the retrieval catheter is radiopaque for
placement visualization. Postprocedure, the clinician aspirates the emboli,
retracts the filter into the retrieval catheter, and removes the entire system from
the patient.
3.0 INDICATIONS FOR USE
The FiberNet Embolic Protection System is indicated for use as a guidewire and
emboli protection system to capture and remove embolic material (thrombus/
debris) produced while performing percutaneous transluminal interventional
procedures in carotid arteries and saphenous vein grafts with reference vessel
diameters of 3.5 mm to 7.0 mm.
4.0 CONTRAINDICATIONS
The FiberNet Embolic Protection System is contraindicated under these
circumstances:
■
Do not use in total chronic occlusions.
■
Do not use in vessels with excessive tortuosity.
■
Do not use in patients with bleeding disorders.
■
Do not use if massive peripheral vascular disease does not allow
vascular access to the target lesion.
Do not use if there is not appropriate space distal to the lesion to place
■
the device.
5.0 WARNINGS
■
Only physicians trained in percutaneous, intravascular techniques and
procedures should use this system.
■
The system is nonpyrogenic and is supplied sterile, using irradiation.
■
This device is designed and intended for single use only. DO NOT
RESTERILIZE AND/OR REUSE. Reuse or resterilization may 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. Reuse 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, and death.
Medtronic will not be responsible for any direct, incidental, or
consequential damages resulting from resterilization or reuse.
■
Do not undersize the filter with regard to the target vessel diameter to
avoid inadequate vessel coverage and filter efficiency in capturing
emboli. Refer to the instructions supplied with any interventional devices
used in conjunction with the system for their intended uses,
contraindications, warnings, precautions, and instructions for use.
■
Exercise care when handling and loading devices over the proximal end
of the capture wire to avoid kinking.
■
Do not use the retrieval catheter for delivery or infusion of diagnostic,
embolic, or therapeutic materials into blood vessels, as it has not been
designed for these uses.
■
Use an appropriately-sized guiding catheter or sheath with a Tuohy Borst
adapter when using this system.
■
To avoid damaging the filter integrity, do not use force when retrieving the
filter.
6.0 CAUTIONS
■
Crossing a freshly deployed drug-eluting stent could damage the delicate
drug coating.
7.0 PRECAUTIONS
■
Store at controlled room temperature, in a dry place. Keep away from
sunlight.
■
Do not autoclave or expose the system to organic solvents.
Confirm compatibility of capture wire/catheter diameter and length with
■
interventional devices prior to use.
■
Use the system prior to the Use By date noted on the package.
■
Prior to use, carefully inspect the capture wire and catheter for bends,
kinks or other damage. Do not use damaged devices or devices
suspected of damage.
■
Carefully handle the capture wire and catheter before and during a
procedure to reduce the possibility of damage.
■
Confirm that the filter is thoroughly saturated with heparinized saline or
an equivalent solution.
■
Do not test (actuate) the filter prior to use.
0110105-00
Medtronic Confidential
■
If using heparin, achieve an ACT near 300 seconds (>200 seconds if
using GPllb/llla Inhibitors).
■
Always advance or retract the system components carefully and slowly
through the vasculature, particularly when crossing stents. Never
advance or withdraw devices against resistance. Determine the cause of
resistance under fluoroscopic imaging and take any necessary action.
■
If the filter cannot cross the lesion and dilation with an angioplasty balloon
on a second wire is required, the filter should not be within the lesion
during the dilation.
■
The filter, once actuated, should be observed under fluoroscopy during
catheter exchange to be sure the filter does not move. The capture wire
should be treated like any standard wire during exchanges.
■
Keep the filter in the retracted position when advancing or repositioning.
■
If excessive debris is collected in the filter and blood flow becomes
obstructed, use the retrieval catheter and remove debris or rapidly
complete the procedure and then remove the filter.
■
In the body, manipulate the catheter only under fluoroscopy. Do not
attempt to move the device without observing the resultant tip response.
■
Do not flush the catheter while it is in the patient.
■
To address lesions in subsequent vessels, use a new system for each
vessel.
8.0 POTENTIAL ADVERSE EFFECTS
Possible adverse effects with intervention and use of this device include, but are
not limited to:
■
access site complication (eg, arteriovenous [AV] fistula, hematoma,
hemorrhage, pseudoaneurysm, puncture site infection, surgical repair)
■
allergies, or other reactions, to procedure medications or device
materials
■
amaurosis fugax (carotid only)
■
aneurysm
■
angina/unstable angina
■
intracerebral bleeding (carotid only)
■
neurological events
■
no/slow reflow of treated vessel
■
pericardial tamponade
■
renal insufficiency/renal failure
■
seizure (carotid only)
■
severe hypotension or hypertension
■
stent damage, migration, misplacement, thrombosis
■
vessel spasm, dissection, rupture, perforation, thrombosis, restenosis
9.0 INSTRUCTIONS FOR USE
9.1 SIZE SELECTION
Estimate vessel diameter where the device will be placed. The filter should be
placed proximal to any side branch requiring protection.
9.2 PREPARATION - Capture Wire
1. Open the shelf box and inspect the pouch for damage.
Caution: Do not use the device if the packaging is damaged or if sterility
appears to be compromised.
2. Open the pouch using a standard sterile handling procedure.
3. Place the protective coils and accessory kit into the sterile field on a flat
surface.
4. Unclip the section of protective coil covering the filter.
5. Remove and discard this section of coil.
6. Saturate the filter by dipping it into heparinized saline or an equivalent
solution.
7. Remove the protective coil from the capture wire. Examine the filter and
tip for any damage or defects.
8. If desired, attach a standard wire torquer onto the proximal end of the
capture wire.
9. If desired, carefully shape the capture wire distal tip to facilitate
navigation through the vessels.
9.3 PREPARATION - Retrieval Catheter
1. Remove the retrieval catheter from the protective coil.
2. Fill the syringe with 10 mL to 20 mL of saline or equivalent solution.
3. Attach extension tube with stopcock to the catheter and attach the
syringe to the extension tube.
4. Open the stopcock and flush the entire catheter.
5. Close the stopcock.
6. Remove the syringe and set aside for future use.
Caution: Do not attach the syringe until the catheter has been tracked
in the vessel and positioned. Attaching the syringe prior to this will
hamper navigation of the catheter.
9.4 INSERTION AND PLACEMENT
Note: Always use a guiding catheter or sheath with an appropriate diameter and
a Tuohy Borst adapter.
1. Sheath the filter by advancing the peel-away introducer over the filter.
2. Insert the capture wire/introducer assembly into the Tuohy Borst adapter
of a guiding catheter or sheath.
3. Close the adapter around the peel-away introducer and allow back-
bleeding.
CS0048
Instructions for Use English 7
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