Tierrett Guidewire
Instructions for use
Contraindicated to re-use[Intended purpose, efficacy or effect]
Temporarily used to assist the position adjustment and movement of stents tobe inserted into the body. (Except for inserting into blood vessels and using)[WARNINGS]<Using method>[1] After inserting the guide wire, make sure to check that the position isappropriate under fluoroscopy.
[There is a possibility of damage to the renal pelvis and ureter, bending,damage, cutting, etc. of this product.][2] If it felt resistance during operation, check the cause under fluoroscopy
and take appropriate measures.
[If operated forcibly, there is a possibility of damage to the renal pelvis
and ureter, bending, breakage, and cutting of this product.][Operating or using method]
The below is a general procedure.
[1] Remove the guidewire together with the dispenser from the packaging.
[2] Fill the dispenser with saline or sterile distilled water from the luer connector
using a syringe.
[3] Remove the guide wire from the dispenser.
[4] Check that the surface slips by touching with your fingers.
[5] Fill with the lumen of a stent etc. to be used in advance by injecting saline orsterile distilled water.
[6] Remove this product carefully after inserting into the body by referring to thepackage insert of the stent to be used.

[CONTRAINDICATIONS・PROHIBITION]

Do not reuse the product (single use only).
[Shape, structure, principle]
This product is sterilized with ethylene oxide gas.

<Precautions for the using method>[1] If the product cannot be removed from the dispenser, twist gently thedispenser to spread water over the entire surface of the product. If it stillcannot take out, release the winding of the dispenser to some extent and takeout.
[2] Use with the surface wet.
[If the surface is not wet, slipperiness cannot be maintained.][3] If it felt a decrease in slipperiness, try to inject water.
[If this product in a dry state is rubbed in a combined medical device, thehydrophilic coating may be peeled off.][4] When holding this product, use gauze soaked in saline or sterile distilled water.
Never use dry gauze.
[The surface may be damaged and resistance may increase when reinsertinginto the combined medical device.][5] Make sure to check under fluoroscopy during the procedure.
[There is a risk of perforating and damaging the inside of the urinary tract
with the tip of this product during the insertion procedure.]

Inner core

<Shape>Total length

O.D.

Flexible length

Tip shape (angle)

Hydrophilic coating

Resin coating (rediopaque)
Inducer
Hydrophilic guidewire

Cavity clipﾟ
Lure connector

Dispenser

Hydrophilic guidewire
Specification

Tip shape

16-60-3T-MA-B

Angle

18-60-3T-MA-B

Angle

O.D.

Totallength

Flexiblelength60cm

3.0cm

60cm

3.0cm

0.41mm(0.016”)0.46mm(0.018”)<Raw Materials>
・Hydrophilic guidewire
Coating resin: Polyurethane
Inner core: Ni-Ti alloy
Hydrophilic coating:
Poly (methyl vinyl ether / maleic anhydride) copolymer
・ Dispenser: Polyethylene
・ Cavity clip: Polyethylene
・ Inducer: Modified polyphenylene oxide
・ Lure connector: Polypropylene<Principles>
The surface of this product has a hydrophilic coating, it shows lubricity after
wetting. Inserted into the lumen of a stent etc. and urinary organs and placing thestent etc. along the product, it becomes easy to assist the position adjustment andmovement of the stent etc.

[Precautions]<Important basic caution>[1] Do not perform an inspection by MRI (Magnetic Resonance Imaging), withthis product placed in the patient.
[Due to the influence of the high-frequency electromagnetic field of MRI, themetal part may cause local high-frequency heating and cause burns to thepatient.][2] Do not pinch the device with forceps too strongly.
[May cause broken giudewire.][3] Do not use the guidewire and metal needle together.
[Peeling of the hydrophilic coating layer, peeling of the coating resin, breakage
and cutting may occur.][4] Do not use metal torque devices.
[May cause damage to the guidewire.][5] When this product is used in cases with extreme stricture of the ureter, there isa risk of tissue and urethral mucosal damage.
[6] When cleaning the surface of the guidewire, soak in a tray containing saline orsterile distilled water and rinse. If it is difficult to remove the dirt, wipe off
gently with gauze soaked in saline or sterile distilled water. At this time, never
rub strongly or wipe with dry gauze.
[Hydrophilic coating may be damaged.][7] Do not immerse in chemicals containing organic solvents such as rubbing
alcohol or wipe with chemicals.
[The guidewire may be damaged or cut, the hydrophilic coating may bedamaged.]

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<Failures・Adverse events>
Failures
The following failures may be caused by the use of the product:[1] Reduced slipperiness[The hydrophilic coating may be damaged due to the following causes andthe slipperiness may decrease.]
・Use in a dry state.
・Operations such as unreasonable insertion and removal.
・Immersion or wiping with drug solution.
・Other combined causes due to the above events.
[2] Breakage, bending, damage, or cutting of the guidewire[The guidewire may be broken, bent, or cut due to the following causes]
・Used in combination with metal needles and metal torque devices.
・Insertion or removal with excessive force or operation with excessivetorque.
・Use for kinked stents, etc.
・Other combined causes due to the above events.
[3] Impossibility of the guidewire removal.
[May become impossible to remove due to the following causes.]・Breakage, bending, damage, or cutting of the guidewire.
・Reduced slipperiness.
・Excessive insertion into the ureter.
・Use for kinked stents, etc.
・Other combined causes due to the above events.
[4] Damage to stents etc.
[Stents etc. may be damaged due to the following causes.]・Insertion or removal with excessive force or operation with excessivetorque.
・Breakage, bending, damage, or cutting of the guidewire.
・Reduced slipperiness.
・Other combined causes due to the above events.
Adverse events
The following adverse events may be caused by the use of the product:
・ Fever・ Hematuria (bleeding)・ Pain・ Infection
・ Bloodstream
・ Pyelonephritis
・ Renal dysfunction
・ Ureter damage (perforation)
・ Frequent urination[Storage conditions and duration of use]
<Storage conditions>Store the product hygienically, avoiding the direct sun light, high humidity andultraviolet rays such as a sterilizing lamp and taking care of wetting.
< Expiration date >See the expiration date given on each package provided that the device is storedappropriately.
[By self-authentication (our data).]

Manufacturer
CREATE MEDIC CO.,LTD.
2-5-25 Chigasakiminami, Tsuzuki-Ku, Yokohama, Japan
In-house administration number: DC67879

R0-0 2020.11.5

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