10/115(3210-1)
When using the catheter inserted in the introducer sheath or
guide catheter
1) When using the catheter in the guide catheter, loosen the
hemostatic valve while keeping it tight enough to prevent
blood leakage.
2) Gradually insert the catheter, with the balloon deflated
completely, into the introducer sheath or guide catheter
over the guidewire and advance to the distal periphery of the
lesion. Under fluoroscopy, advance the catheter slowly to
make its radiopaque marker in the balloon reach the target
site.
3) Under fluoroscopy, verify the position of the radiopaque
marker in the balloon and determine the dilatation site.
4) Attach the inflation device securely to the balloon inflation
port.
5) Inflate the balloon gradually to the target diameter verifying
the inflation pressure and dilate the stenotic lesion (for
inflated balloon diameters, consult the balloon compliance
chart provided in Table 1. at the end of this Instructions for
Use).
4. Removal of the catheter
1) After applying negative pressure to deflate the balloon
completely, remove the catheter.
5. Re-insertion of the catheter
1) If a re-insertion of the removed catheter with deflated
balloon is required, ensure the balloon is completely deflated
and folded before re-inserting it into the patient’s blood
vessel. On re-insertion use the catheter as per “Insertion
and inflation of the balloon catheter” section herein.
2) If any resistance is encountered while re-inserting the
catheter, stop advancing it and carefully remove it out of the
patient’s blood vessel. Prepare to use a new Metacross
OTW in accordance with the procedures provided above in
this section of this Instruction for Use.
[Complications]
Device Failures:
・
Balloon rupture
・
Insufficient inflation / deflation of the balloon
・
Breakage of the balloon and / or the catheter shaft
・
Difficulty in removing the device
・
Leakage of inflation fluid
Adverse Events:
・
Local or systemic infections
・
Local internal bleeding or hematoma
・
Intimal rupture
・
Vascular dissection
・
Vascular perforation
・
Vascular rupture
・
Aneurysm
・
Arrhythmia
・
Acute vascular occlusion
・
Venous thromboembolism
・
Vasospasm
・
Formation of pseudoaneurysm
・
Arteriovenous fistula
・
Bleeding requiring transfusion
・
Allergic response to the contrast media / renal failure
・
Ache or pressing pain
・
Death
・
Embolism
・
Endocarditis
・
Fever
・
Hypertension / Hypotension
・
Inflammation
・
Myocardial Infarction
・
Sepsis
・
Shock
・
Stroke
・
Transient Ischemic Attack
[Storage and expiration date]
1. Store in a cool, dry, dark place. Avoid exposure to water, direct
sunlight.
2. The expiration date is indicated on the box. Do not use after the
expiration date.
[Package]
1 set/box
[Name and address of manufacturer]
Manufacturer : KANEKA CORPORATION
Address: 3-18, 2-chome, Nakanoshima, Kita-ku, Osaka-city,
OSAKA, 530-8288 JAPAN
TEL No.: (+81)-(0) 6-6226-5256
FAX No.: (+81)-(0) 6-6226-5143
Authorized representative in the European Community:
KANEKA PHARMA EUROPE N.V.
Address: Nijverheidsstraat 16, 2260 Westerlo-Oevel, Belgium
TEL No.: (+32)-(0) 14-256-297
FAX No.: (+32)-(0) 14-256-298
EU Distributor : TERUMO EUROPE N.V.
Address: INTERLEUVENLAAN 40,3001 LEUVEN, Belgium
TEL No.: (+32)-(0) 16 381 211
FAX No.: (+32)-(0) 16 400 249
USA Distributor : TERUMO MEDICAL CORPORATION
Address: 2101 Cottontail Lane, Somerset, NEW JERSEY,
08873, U.S.A.
TEL No. : (+1) 800-888-3786
FAX No.: (+1) 800-411-5870
Terumo and METACROSS are trademarks of TERUMO
CORPORATION.
