Tierrett Ureteral Stent
Instructions for use
Contraindicated to re-use[WARNINGS]<Using method>[1] When using this product, consider the urinary tract length of the patient
before use and confirm that the pigtail part is not excessively formed.
Also, consider using other tip shape types depending on the risk.
[There is a risk of knot at the tip of the renal pelvis during placement orremoval.][2] After inserting the stent, make sure to confirm that the stent position isappropriate under fluoroscopy.
[3] The lumen of the stent tube may be blocked by urine components andstones etc.
[4] If resistance is felt during removal, check the cause of the resistance withX-rays and take appropriate measures.
[If it is forcibly removed, it may damage the renal pelvis and ureter.][CONTRAINDICATIONS・PROHIBITION]

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

Side hole
Stent tube (radiopaque)

Effective length

・Dailator tube
Chamfering

Tapered part

Hydrophilic coating

Dailator tube (radiopaque)

Total length

Hydrophilic coating[Intended purpose, efficacy or effect]
Inserted and placed in the ureter and used for drainage, drainage, cleaning, etc.
[Operating or using method]
The below is a general procedure.
<Placement method from the renal pelvis (antegrade)>[1] Insert an indwelling needle from the surface of the kidney to the renal pelvis andinsert the dilator tube to the distal side of the ureter while handling the tip of theouter tube.
[2] Insert the guidewire into the dilator tube and insert to the bladder. (For theguidewires recommended for this product, refer to the section <Medical devices
used in combination>.)[3] Pull out the dilator tube and insert the stent tube along the guidewire.
[4] Insert the dilator tube again along the guidewire, push one side of the stent tube
into the bladder, then remove the dilator tube.
[5] Make an incision on the ventral side of the bladder, remove the guidewire fromthe incision slowly while holding the stent tube.
[6] Place the stent tube in place. Confirm that a loop has formed in the bladder andrenal pelvis.
[7] The incision on the ventral side of the bladder is sutured and closed.
<Placement method from the bladder (retrograde)>[1] Insert a guidewire into the stent tube and straighten the loops at both ends.
(For the guidewires recommended for this product, refer to the section<Medical devices used in combination>.)[2] Make an incision on the ventral side of the bladder, insert the set stent tube andguidewire through the urine outlet.
[3] Stop insertion when the tip of the stent tube reaches the renal pelvis. (Figure 1)[4] While holding the guidewire, push the stent tube forward and confirm that thetip has looped in the renal pelvis. (Figure 2)[5] Slowly remove the guidewire while supporting the end of the stent tube.
(Figure. 3)[6] Confirm that a loop is formed on the bladder side. (Figure. 4)[7] The incision on the ventral side of the bladder is sutured and closed.

Stent tube
Size

O.D.

2.1Fr

0.71mm

2.5Fr

0.83mmEffective
length80, 100, 120,0.45mm
140, 160mm
120, 140,0.53mm160mm
I.D.

Hydrophilic
coatingYes(surface only)Yes(surface only)

SideholeYes
Yes

Renal pelvis
Guidewire
UreterStent
Bladder

Dilator tube
SizeO.D.

I.D.

Total length

For 2.1Fr

0.73mm 0.53mm

300mm

For 2.5Fr

0.86mm 0.53mm

300mm

Hydrophiliccoating
Yes(surface only)Yes(surface only)(Figure. 1)<Raw Materials>
・Stent tube: Polyurethane
・Dilator tube: Nylon
・Hydrophilic coating: Poly (methyl vinyl ether / maleic anhydride) copolymer

Push only the stent(Figure. 2)

Pull out the guidewire slowly.

<Principles>
Inserted into the ureter and fixed and placed in a loop shape. Urine is drained
through the surface and lumen.

(Figure. 3)

1／2

Form a loop on the bladder side

(Figure. 4)

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<Placement method from ureteral incision>[1] Insert a guidewire into the stent tube and straighten the loops at both ends.
(For the guidewires recommended for this product, refer to the section<Medical devices used in combination>.)[2] Insert the set stent tube and guidewire from the ureteral incision toward thebladder side.
[3] Make an incision on the ventral side of the bladder, remove the guidewire fromthe incision slowly while holding the stent tube. At this time, the loop partshould protrude from the ureteral incision part.
[4] Insert the guidewire again from the stent tube on the bladder side andstraighten the loops at both ends.
[5] The stent tube and guidewire are pulled back into the urinary tract and theninserted into the renal pelvis.
[6] Stop insertion when the tip of the stent tube reaches the renal pelvis. (Figure 1)[7] While holding the guidewire, push the stent tube forward and confirm that thetip has looped in the renal pelvis. (Figure 2)[8] Slowly remove the guidewire while supporting the end of the stent tube.
(Figure. 3)[9] Confirm that a loop is formed on the bladder side. (Figure. 4)[10] The incision on the ventral side of the bladder is sutured and closed.

・ Fever・ Hematuria (bleeding)・ Pain・ Infection
・ Bloodstream
・ Pyelonephritis
・ Renal dysfunction
・ Ureter damage
・ 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).]<Removal method>
Grasp the end of the catheter from the bladder with forceps and gently pull out.

Manufacturer
CREATE MEDIC CO.,LTD.
2-5-25 Chigasakiminami, Tsuzuki-Ku, Yokohama, Japan<Medical devices used in combination>
When using this product, use it in combination with the following medicaldevices.
Guidewire recommended for this productProduct nameO.D.
Total length
Adaptation
0.41mm
600mm or more
2.1Fr
(0.016”)
Tierrett Guidewire
0.46mm
600mm or more
2.5Fr
(0.018”)In-house administration number: DC67878

R0-0 2020.11.2[Precautions]<Important basic caution>[1] Do not pinch the device with forceps too strongly.
[May cause broken stent tube and dilator tube, and occlusion of lumen.][2] When this product is used in cases with extreme stricture of the ureter, there is arisk of tissue and urethral mucosal damage.
[3] Do not immerse in chemicals containing organic solvents such as rubbing
alcohol or wipe with chemicals.
[The stent tube and dilator tube may be damaged or cut, or the hydrophilic
coating may be damaged.]<Failures・Adverse events>
Failures
The following failures may be caused by the use of the product:[1] Occlusion of the catheter.
[The lumen of the stent tube may be occluded by the adhesion of the urinary
constituents or blood clots etc.][2] Cut of stent tube and dilator tube.
[Cut due to the following causes]
・Damage caused by handling during insertion (Damage caused by forceps,
scissors, knife or other apparatuses)
・Damage due to the calculus in the patient.
・Sudden load on the product such as self (accidental) removal.
・Other combined causes due to the above events.
[3] Breakage, bending, damage, or cutting of the stent tube
[The stent tube may be broken, bent, or cut due to the following causes]
・Insertion or removal with excessive force or operation with excessive torque・Other combined causes due to the above events.
Adverse events
The following adverse events may be caused by the use of the product:

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