Merit Medical Worley Advanced LVI Lateral Vein Introducers - Manual (Page 3)

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¡ Air embolism
¡ Allergic reaction to contrast media
¡ Arterial wall damage
¡ Bleeding
¡ Cardiac arrhythmias
¡ Cardiac tamponade
¡ Chronic nerve damage
¡ Damage to the heart valves
¡ Hematoma at the puncture site
¡ Infection
¡ Local tissue response, fibrotic tissue formation
¡ Myocardial damage
¡ Myocardial infarction
¡ Plaque dislodgement
¡ Pneumothorax
¡ Stroke and death
¡ Thrombus formation/emboli
¡ Vascular occlusion
¡ Vascular spasm
¡ Venous or cardiac perforation
Warnings
¡ This product is sensitive to light. Do not use if stored
outside the protective outer carton. Store in a cool,
dark, and dry place.
¡ Infusion through the side port can be done only
after all air is removed from the unit. Improper use
of the transvalvular insertion tool (TVI) can cause air
embolism and back bleeding.
¡ Do not use this device in patients who cannot be
appropriately anticoagulated. When tested in non-
anticoagulated sheep, this device has shown thrombus
formation, however, heparinized studies alleviated the
concern.
Precautions
¡ Do not alter this device in any way.
¡ Single Use Devices: This single-use product is not
designed or validated to be reused. Reuse may cause
a risk of cross-contamination, affect the measurement
accuracy, system performance, or cause a malfunction
as a result of the product being physically damaged
due to cleaning, disinfection, re-sterilization, or reuse.
¡ Federal law (U.S.A.) restricts this device to sale by or on
the order of a physician.
¡ Aspiration and saline flushing of the sheath, dilator,
and valve should be performed to help minimize the
potential for air embolism and clot formation.
¡ Indwelling introducer sheaths should be internally
supported by a catheter, electrode pacing lead, or
dilator wire.
¡ Dilator wires, catheters, and pacing leads should be
removed slowly from the sheath. Rapid removal may
damage the valve members resulting in blood flow
through the valve. Never advance or withdraw guide
wire or sheath when resistance is met. Determine cause
by fluoroscopy and take remedial action.
¡ When injecting or aspirating through the sheath, use
the side port only.
¡ When using the transvalvular insertion tool (TVI), lead
size may not exceed 6.2F.
¡ When using the TVI always keep the exposed proximal
end covered to prevent air embolization and back
bleeding.
Use Sterile Technique A suggested procedure:
1. After placement of either a Braided or Peel Away
9F CSG in the mid coronary sinus, occlusive balloon
venography is performed preferably in both the RAO
and LAO projections. An appropriate posterolateral
coronary sinus tributary is then selected.
2. Depending upon the take-off angle of the venous
tributary, an appropriate 7F Braided Telescopic Lateral
Vein introducer is selected.
3. A guide wire is advanced to a position in the coronary
sinus beyond the chosen lateral vein and the 7F
Telescopic Braided introducer is advanced to the desired
location.
4. Advance the 5 French catheter over the retained wire
through the LVI.
5. Using fluoroscopy and small ‘puffs’ of contrast material
manipulate the tip of the 5 French catheter into the
target vein. Sub-selective venography may then be
performed if desired.
6. Advance the LVI over the 5 French catheter into the
target vessel.
7. Remove the 5 French catheter leaving the LVI in the
target vessel.
8. If a stylet driven pacing lead is chosen, it is then
advanced through the LVI Telescopic introducer and
tested.
9. If an over the wire lead is used, the angioplasty wire is
advanced through the LVI Telescopic introducer as far as
it will go in the sub-selected vessel. The ‘over the wire’
lead is then advanced over the angioplasty wire to the
desired pacing location.
10. In either case, when the lead position is correct
fluoroscopically and electrically, the LVI Telescopic
introducer is withdrawn into the CSG while lead
position is observed fluoroscopically.
11. Use either the Cutter (Model #CUT) or a Medtronic Slitter
(Model #6228SLT) to remove the braided introducer
from the lead. For the Cutter, see “Cutter Directions for
Use” below.
NoTE: The Cutter or Medtronic Slitter is to be used after
pacing lead or catheter is in the desired location and the
sheath introducer is ready to be removed. It is suggested
the lead stylet or angioplasty wire be retained during
sheath removal.
NoTE: The Telescopic introducer should always be removed
prior to removal of the CSG sheath.
Cutter Directions for Use
To aid in removal of a braided sliceable introducer after it has
been used to place a pacemaker lead or catheter.
Precautions
Do not alter this device in any way.
Federal law (U.S.A.) restricts this device to sale by or on the
order of a physician.
As specified in the following chart, use an introducer sheath
and pacing lead within the parameters listed in the chart
below.
Largest Largest
Introducer Size Lead Size
4.0mm/12F 2.0mm/6F
Suggested Directions for Use
The Cutter is to be used after pacing lead or catheter is in
the desired location and the sheath introducer is ready to be
removed. It is suggested a lead stylet or stiffening wire be
retained in the pacing lead during sheath removal.
If cutting a CSG Braided Series Sheath:
1. Open package and place contents on sterile field.
2. It is suggested that the braided sheath be withdrawn to
the furthest extent possible prior to splitting the sheath
valve and cutting the sheath.
Note: The lead tip and lie of the lead along the RA
floor should be carefully observed fluoroscopically
as the braided sheath is withdrawn and cut, to avoid
inadvertent lead dislodgment.
3. Manually split the handles of the sheath valve. One half
of the valve will remain attached to the braided sheath.
Dispose of the other valve section. (see Figure 1)
4. Position the distal ‘C’ section of the Cutter under the
sheath tubing, distal to the sheath hub. (see Figure 2)
5. Place the blade hook into the ‘V’ notch of the tubing at
the proximal end of the sheath. (see Figure 3)
6. Thread the pacing lead over the notch at the back
end of the Cutter and compress the lead with
your thumb, while holding the Cutter in a ‘pistol grip’
fashion. (see Figure 4)
7. While holding the Cutter and the lead with one hand,
slowly withdraw the braided sheath over the Cutter
blade with the other hand. As the sheath is withdrawn
it is cut away from the lead in the process. (see Figure 4)
If cutting a braided Lateral Vein Introducer (LVI)
within a CSG sheath:
1. Open package and place contents on sterile field.
2. With a stabilizing stylet or stiffening wire in place, and
while holding the lead in place, under fluoroscopic
control, withdraw the LVI into the distal end of the
CSG. (see Figure 5)
Note: The lead tip should be carefully observed
fluoroscopically as the LVI sheath is withdrawn and
cut, to avoid inadvertent lead dislodgment. The outer
CSG sheath should be stabilized by an assistant grasping
the CSG distal to the CSG hub as the LVI is withdrawn
and cut to prevent inadvertent dislodgement of the CSG
outer sheath from the mid CS.
3. Manually split the handles of the LVI sheath valve. One
half of the valve will remain attached to the braided LVI.
Dispose of the other valve section. (see Figure 6)
4. Position the distal ‘C’ section of the Cutter under the LVI
sheath tubing distal to the sheath hub. (see Figure 7)
5. Place the blade hook into the ‘V’ notch of the LVI tubing
at the proximal end of the LVI guide. (see Figure 3)
6. While maintaining the LVI Guide, pacing lead and CSG
Sheath in position, hold the Cutter in ‘pistol grip’ fashion
and cut the LVI by advancing the Cutter toward the CSG
sheath until the distal ‘C’ portion of the Cutter engages
the CSG hub. (see Figure 8)
Note: Make sure the pacing lead, LVI guide and CSG
sheath are not advanced or withdrawn with the Cutter
during this step of the procedure.
7. After the Cutter has engaged the CSG hub, thread
the pacing lead over the notch at the back end
of the Cutter and compress the lead with your
thumb. (see Figure 9)
8. While holding the Cutter engaged with the CSG hub and
lead with one hand, slowly withdraw the LVI sheath
over the Cutter blade with the other hand. As the LVI is
withdrawn it is cut away from the lead in the process.
(see Figure 9)
Note: The outer CSG sheath should continue to be
stabilized distal to the CSG hub as the LVI is withdrawn
and cut to prevent inadvertent dislodgment of the CSG
outer sheath from the mid CS.
9. After the LVI is cut and removed the CSG is removed as
described above under the heading “If cutting a CSG
Braided Series Sheath,” or in the appropriate DFU.
da-Brugsanvisning
Denne anordning er udelukkende beregnet til engangsbrug.
Læs instruktionerne før brug.
Indikationer
Til indføring af forskellige typer pace- eller
defibrillatorelektroder og katetre.
Flettede laterale veneindførere er beregnet til
selektiv koronar sinusvenografi og/eller placering af
pacemakerelektroder i specifikke tilløb til koronar sinus.
Kontraindikationer
Brugen af Coronary Sinus Guide / Lateral Vein Introducer
(CSG/LVI) systemerne er kontraindikeret af det følgende:
¡ Patienter med en eksisterende eller mulig okklusion af
koronarkar eller uegnet kransblodåreanatomi.
¡ Patienter med aktiv systemisk infektion