Directions For Use - BIOTRONIK Passeo-18 Lux Instrucciones De Uso

Potential Adverse Events/Complications
Possible adverse events associated with the included drug (Paclitaxel)
and delivery matrix (BTHC):
• Allergic/immunologic reaction to the drug (Paclitaxel or structurally
related compounds) or to the balloon delivery matrix n-Butyryl tri-
n-hexyl citrate (BTHC).
• Alopecia.
• Anaemia.
• Blood-/Blood product transfusion.
• Gastrointestinal symptoms.
• Haematological dyscrasia (incl. leukocytopenia, neutropenia,
thrombocytopenia).
• Hepatic enzyme changes.
• Histological changes in the vascular wall, incl. inflammation, cell
damage or necrosis.
• Disorders of the heart conduction system.
• Myalgia / arthralgia.
• Peripheral neuropathy.
• Pseudomembranous colitis.
• Mutagenic effects.
Note: The very small quantity of paclitaxel in the blood plasma means
that the classic undesirable effects caused by paclitaxel appear
less relevant than for a systemic treatment. However, side effects
yet unknown cannot be ruled out.
Possible adverse events associated with PTA procedure include, but
are not limited to:
• Balloon catheter events: Failure to reach or cross the lesion, inflation
difficulties, rupture or pinhole of the balloon, deflation difficulties,
withdrawal difficulties, embolization of catheter material.
• Vascular events: Injury to the vessel wall, intimal tear, arteriovenous
fistula formation, pseudoaneurysm formation, vessel spasm,
embolization of air, thrombotic or atherosclerotic material,
restenosis of the dilated vessel, total occlusion of the vessel
• Neurologic events: Peripheral nerve injury.
• Bleeding events: Access site bleeding or hemorrhage, hemorrhage
requiring transfusion or other treatment.
• Accompanying medication related events: Side effects per
corresponding package leaflet.
• Allergic reactions to contrast media, antiplatelets, anticoagulants.
• Death.
• Infections.
There may be other potential adverse events that are unforeseen at
this time.
Medication Schedule
Appropriate anticoagulant, antiplatelet and vasodilatation therapy
should be administered to the patient.
The following medication regimen is solely intended as a possible
guide-line and should not be seen as a strict guidance.
Pre-procedure medication regimen:
• ASA 300 mg 12 hours before procedure.
• Clopidogrel 300 mg 12 hours before procedure.
Procedural medication regimen:
• Intraarterial bolus of heparin (3000 – 5000 U).
Post-procedure medication regimen:
• ASA 100 mg daily indefinitely.
• Clopidogrel 75 mg daily for 4 weeks (check leukocyte count and
platelet count after 2 and 4 weeks).

Directions for Use

Caution: Touching of the balloon, wiping of the balloon surface or any
contact with liquids prior to insertion should be strictly avoided,
since this could damage the balloon coating.
Passeo-18 Lux catheter selection
Select an appropriate balloon for the target vessel. The diameter of
the balloon should closely match the reference diameter of the target
vessel.
Caution: The inflation diameter of the balloon must not exceed the
diameter of the target artery proximal or distal to the stenosis.
Select a balloon length which closely matches the lesion length. If the
stenosis cannot be crossed with the desired Passeo-18 Lux catheter,
a smaller diameter non drug-coated PTA catheter can be used before
finally dilating with a Passeo-18 Lux catheter.
6
IFU Passeo-18 Lux Version D.indd 6
Caution: For prevention of local overdosing it is not indicated to use a
second Passeo-18 Lux catheter or any other drug-coated balloon
at the same treatment site respectively. Also the implantation of
a drug eluting stent at the same site should be avoided since an
over-dosage or interaction between the active agents cannot be
excluded.
Caution: In case of the treatment of long lesions (longer than max.
balloon length available) the individual segments should be treated
with only one Passeo-18 Lux catheter. For each segment another
Passeo-18 Lux catheter should be used while overlapping with an
already treated segment should be avoided in order to prevent any
local overdosing.
Passeo-18 Lux catheter preparation
1. Take the protection ring with the device out of the package and
place it onto a sterile field.
Caution: It is recommended to use gloves, mouth, nose and an eye
protection in the unlikely event that the active compound of the
balloon coating is released prior to insertion of the Passeo-18
Lux catheter into the introducer sheath. Potentially, the released
particles may enter the respiratory tract.
2. Gently withdraw the dilatation catheter from the protection ring.
Caution: DO NOT remove yet the insertion aid in order to avoid any
contact with the balloon coating.
Caution: DO NOT bend or squeeze the balloon portion of the Passeo-18
Lux catheter before the procedure to prevent delamination of the
drug coating.
Flush guide wire lumen
3. Connect a 10ml or 20ml syringe containing sterile saline to the luer
port of the guide wire lumen at the proximal end of the dilatation
catheter.
4. Flush the guide wire lumen.
5. Remove the syringe.
Purge air from the Passeo-18 Lux catheter
with the insertion aid still in place
6. Fill a 20 ml capacity inflation device with 6 ml of contrast/saline
solution.
7. Remove air from the inflation device according to the
manufacturer's recommendations and instructions.
8. Attach the inflation device to the inflation port of the dilatation
catheter.
Warning: Use only an appropriate balloon inflation medium, (e.g.
50:50 mixture by volume of contrast medium and saline). Never
use air or any gaseous medium to inflate the balloon.
Caution: DO NOT permit air to enter the system.
9. Pull back on the plunger and aspirate for 30 seconds until no
bubbles appear inside the barrel of the inflation device during
aspiration. Repeat this process several times if necessary.
10. Return to neutral pressure.
Pre-treatment of significant stenosis
Caution: Pre-treatment of significant stenosis (> 50%) proximal to
target lesion is required to prevent delamination of the balloon
coating during crossing the lesion.
Preparation of insertion aid
Raised portion
Distal End
Figure 1: Insertion aid features.
11. Advance the balloon inside the insertion aid to ensure the distal tip
of the balloon is visible beyond the distal end of the insertion aid
(Figure 2). DO NOT REMOVE insertion aid.
Figure 2: Distal tip of the balloon visible beyond distal end of
insertion aid.
Insertion technique
12. If not already done, position the guide wire, under fluoroscopic
guidance, in accordance with standard percutaneous transluminal
angioplasty (PTA) techniques.
13. Push the distal tip of the Passeo-18 Lux catheter onto the proximal
end of the guide wire and advance until the guide wire exits the luer
lock at the proximal end of the catheter.
14. Holding the device by the insertion aid (see Figure 3), carefully
insert the Passeo-18 Lux catheter together with the insertion aid
into the introducer sheath until the raised portion of the insertion
aid contacts the valve of the introducer sheath (Figure 4).
Caution: The raised portion must remain partially visible outside the
introducer during insertion.
Figure 3: Insertion aid and catheter advancement into the introducer
Figure 4: Raised portion in contact with the valve of the introducer
15. With one hand, continue holding the insertion aid to maintain its
position. With the other hand, advance the device until the proximal
end of the balloon is inside the introducer sheath.
16. While holding the insertion aid, slide back the insertion aid out of
the introducer sheath and towards the hub of the catheter (Figure
5).
Figure 5: Removing insertion aid from the introducer sheath.
17. If necessary, the insertion aid can be peeled off by pushing it onto
the kink protector and then gently pulling it away from the kink
protector at the proximal end of the shaft (Figure 6).
Crimped segment
Figure 6: Removal of insertion aid (if necessary).
18. Advance the Passeo-18 Lux catheter over the guide wire towards
the lesion.
19. Position the balloon across the lesion using the balloon radiopaque
markers as reference points.
Balloon inflation
20. Inflate the balloon with the inflation device to dilate the lesion
using standard PTA techniques for at least 30 seconds.
Warning: DO NOT exceed Rated Burst Pressure (RBP).
Warning: To reduce the potential of vessel damage, the inflated
diameter of the balloon must not exceed the original diameter of
the vessel proximal and distal to the lesion.
21. If a significant stenosis persists, inflate the balloon again
increasing pressure gradually until the lesion does not further
improve.
sheath.
sheath.
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