Instructions For Use - Boston Scientific FilterWire EZ Gebrauchsanweisung

Preparation of the Protection Wire and EZ Delivery Sheath:
1. Open the pouch using standard sterile handling procedures and place the
packaging coils and accessory tool kit into the sterile field.
2. Unclip and carefully remove the yellow protective housing from the filter.
Note: If damage is found, call your Boston Scientific representative.
Note: The protection wire is preloaded into the EZ Delivery Sheath.
Caution: Do not use the FilterWire EZ System if the yellow protective housing is not
clipped to the coil and the filter and spring coil tip are exposed.
3. Remove the preloaded protection wire from the retaining clip; advance the
EZ Delivery Sheath until the clear section is exposed; then, grasp the clear section
of the sheath, and remove the preloaded protection wire from the packaging coil.
Caution: Do not use the FilterWire EZ System if the retention clip is not clipped onto
the coil with the delivery sheath secured to it.
4. Retain the packaging coil on the sterile field to ensure availability of the
EZ Retrieval Sheath when needed.
5. Attach the wire torquer to the protection wire near the exit port. This will facilitate
retraction of the filter into the EZ Delivery Sheath during preparation.
6. Grasp the EZ Delivery Sheath towards the very distal end of the clear section and
submerge the filter and sheath in heparinized saline.
7. While the filter and delivery sheath are submerged in the heparinized saline,
sheath the protection wire by slowly retracting it into the EZ Delivery Sheath until
the nose cone is partially retracted into the sheath.
Note: Do not over-retract the filter.
Note: Do not sheath the filter until immediately prior to use. Make certain that the
filter is thoroughly saturated with saline prior to retracting the filter into the
EZ Delivery Sheath.
Insertion and Positioning of the FilterWire EZ System:
Warning: Introduce and advance devices slowly to prevent embolism or trauma to
the vasculature.
1. Carefully insert the sheathed protection wire tip into the peel-away introducer. If
desired, shape the spring coil tip of the protection wire. In order to prevent spring
coil tip damage, ensure the tip is retracted inside the peel-away introducer.
2. Advance the FilterWire EZ System and peel-away introducer assembly into the
hemostasis valve attached to a guide catheter or guide sheath.
3. Carefully remove the peel-away introducer.
4. Carefully advance the FilterWire EZ System through the guide catheter or guide
sheath to prevent inadvertent deployment of the filter.
Warning: Do not attempt to move the protection wire without observing the resultant
tip response.
Warning: All distal wire tips have the potential to cause vessel injury. Confirm that the
wire tip is free within the vessel.
39 MB Drawing 50573139
5. Under fluoroscopic imaging, steer the FilterWire EZ System into the target vessel.
Using a two-handed technique, torque the protection wire with one hand and
advance the EZ Delivery Sheath with the other hand.
Note: Always advance the protection wire and EZ Delivery Sheath together to prevent
inadvertent deployment.
Note: Do not allow the protection wire to wrap around the EZ Delivery Sheath shaft to
ensure the filter can be deployed smoothly.
Note: Consider using a "buddy wire" or pre-dilate the lesion if it is tight and difficult
to pass.
Caution: If a buddy wire is used, ensure that the buddy wire does not wrap around
the protection wire.
Caution: If a buddy wire is used, leaving the buddy wire in place during lesion
treatment can lead to vessel trauma or accidental entrapment of the protection wire.
Caution: To avoid device damage, do not pre-dilate the lesion with the sheathed
FilterWire EZ System in the vicinity of the lesion.
6. Advance the FilterWire EZ System across the lesion until the apex of the filter loop
can be deployed in the recommended minimum landing zone (see Table 3 and
Figure 2). This distance should be maintained throughout the procedure.
Warning: Do not use excessive force when attempting to cross the lesion with the
FilterWire EZ System.
Note: If extra landing zone length is available, placing the filter loop beyond the
minimum distance is desirable.
Table 3. Minimum Landing Zone Requirements
FilterWire EZ System (3.5 mm - 5.5 mm)
See Table 3 for Minimum Landing Zone Requirements
Lesion
Guidewire / bare wire Catheter Stop
Figure 2. Minimum Landing Zone
Note: If an interventional device with a tip-to-shoulder length greater than 10 mm
is to be used, a longer vessel length and landing zone may be required to place the
protection wire in order to avoid contact between the protection wire's catheter stop
and the tip of the interventional device.
7. Once the protection wire is advanced past the lesion, slide the wire torquer along
the protection wire and secure it against the hemostasis valve.
5
Minimum Landing Zone should be:
≥ 3.0 cm
Black (K) ∆E ≤5.0