Tierrett Ureter Bypass Tube (Soft type)
Instructions for use
Contraindicated to re-use[WARNINGS]<Usage>[1] Make sure to adhere the fixing plate and catheter.
[Urine leaks due to catheter removal causes peritonitis.][2] Make sure to adhere the fixing plate with the kidney or bladder.
[Urine leaks through the space causes peritonitis.][2] Shave and disinfect (clean, wipe) skin.
[3] Open the abdominal by a midline abdominal incision. Wrap the entire
gastrointestinal tract with a towel or etc. to expose only the target kidney.
- Position determination of the fixing plate on the kidney side[4] The thickness (a) from the renal capsule to the renal pelvis in the central part of[CONTRAINDICATIONS・PROHIBITION]
・Do not reuse the product (single use only).
・Do not use for patients with severe obstruction or disuse of the ureter.

the kidney is measured by ultrasound (echo). Move the fixing plate to a
position where the catheter side holes are placed in the renal pelvis todetermine the fixation position (Fig. 2).

[Shape, structure, principle]
This product is sterilized with ethylene oxide gas.
・Polyvinyl chloride (plasticizer: di (2-ethylhexyl) phthalate) is used for the fixingplate.
<Shape>[5] Bend the catheter at the fixation position to create a space between the fixing
plate and the catheter (Fig. 3). Put medical instant glue between the space (Fig.
4). Move the catheter gently left and right or rotate the fixing plate (Fig. 5).
Make sure that the glue is covered all over the space. After bonding, leave it
two to three minutes to dry and check that it is fixed.
Size

A:Tip length

8.5 Fr, For cats

35 mm

8.5 Fr, For dogs

40 mm

10 Fr, For cats

35 mm

10 Fr, For dogs

40 mm

B:
Effective lengthC:
O.D.
φ2.8 mm

500 mm
φ3.3 mm<Raw Materials>
・Body tube: Polyurethane・Fixing plate: Polyester, Polyvinyl chloride- Position determination of the fixing plate on the bladder side
[6] Place the fixing plate on the bladder side the catheter with a gentle loop to a

<Principles>clockwise. If the catheter is long, cut the catheter end to adjust (Fig. 6). Place

One of the catheter tubes is inserted into the renal pelvis and the other into thethe fixing plate so that the catheter end is inserted into the bladder bybladder to assist urination from the kidney to the bladder.

approximately 1 cm.

[Intended purpose, efficacy or effect]
Placed in the kidney and bladder to assist in urination from the kidney to thebladder.
[Operating or using method]
The below is a general procedure.
[1] Pull out two sheets of the protective sheets and the shape protective wire anddiscard (Fig. 1).

[7] Fix the fixing plate on the bladder side of the catheter by gluing the space inthe same way as in [5].
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[14] Suture the abdominal wall and skin as usual to complete the surgery.

- Catheter placement on the kidney side
[8] While checking the renal pelvis by ultrasound (echo), insert a 18G indwelling<Precautions for the using method>[1] The catheter loop must be loose and as large as possible with a space between
it and the diaphragm.
[It risks catheter disconnection, kink, contact ulcer, etc. due to bodymovement.]

needle from the central part of the kidney toward the renal pelvis until urine
is slowly discharged (Fig. 7). Then, remove the indwelling needle. Dilate acatheter guide hole by re-inserting a micropipette through the hole where theindwelling needle was inserted (Fig. 8). Remove the micropipette. Insert thecatheter tip on the kidney side into the renal pelvis (Fig. 9).

[Precautions]
Carefully apply to the following patients:[1] Check in advance if it is applicable to cases with renal stones.
[The tube may be blocked by stones.]<Important basic caution>[1] Manage appropriately the catheter state during placement. Check theplacement state as required.

[9] While checking the position of the catheter in the renal pelvis by ultrasound[The catheter lumen may be occluded due to breakage, bending, twisting,(echo), inject an appropriate amount of saline from the bladder side of theurine components, stones, etc. of the catheter.]catheter to check inflow into the renal pelvis. Also, check discharge from the[2] Do not pinch the device with forceps too strongly.

bladder side of the catheter. Unless inflow or drainage can be confirmed,[The tube may be cut, or the lumen may be occluded.]remove the catheter once and flush from the bladder side of the catheter to[3] Note that di (2-ethylhexyl) phthalate, which is a plasticizer for polyvinyl
chloride, may elute in fat-soluble pharmaceuticals or chemicals.
[Polychlorinated vinyl chloride is used for the catheter.]check clogging or etc. After re-insert the catheter into the renal pelvis to checkinflow and drainage, glue the felt and the kidney (Fig. 10).

<Failures >[1] Occlusion of the catheter.
[The lumen of the catheter may be occluded by the adhesion of the urinaryconstituents or blood clots etc.][2] Cut of the catheter.
[Cut due to the following causes]
・Damage caused by forceps, scissors, knife or other apparatuses
・Sudden load on the product such as self (accidental) removal.
・Other combined causes due to the above events.

- Catheter placement on the bladder side[3] Catheter disconnection.

[10] Suture on the apex of the bladder by purse string suture and make a small[Disconnection due to the following causes]

incision in the center of the suture (Fig. 11).

・Unbonded, disconnection due to different glue filling position.
・Sudden load on the product such as self (accidental) removal
・Other combined causes due to the above events.
Adverse events
The following adverse events may be caused by the use of the product:
・Infection, bloodstream, fever, pain
・Kidney damage, ulceration, perforation, hematuria (bleeding), stones[11] Make a gentle loop of the entire catheter toward the bladder (Fig. 6).
[12] Insert the catheter end of the bladder side through the small incision. Ligate
purse string suture with the felt of the fixing plate in contact with the serosal
surface of the bladder (Fig. 12). Ligate and fix one of the fixing plate and thefelt with using the suture (Fig. 13). Then, ligate and fix the bladder wall on
the opposite side, the fixing plate, and the felt (Fig. 14).
Fig. 12Fig. 13
Fig. 14

・Urine leakage from the side of the catheter
・Urethral edema and ulcer around the catheter
・Remains in the body due to catheter cutting[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 stored
appropriately.
[By self-authentication (our data).][13] Glue the felt and the bladder wall (Fig. 15).

Manufacturer
CREATE MEDIC CO.,LTD.
2-5-25 Chigasakiminami, Tsuzuki-Ku, Yokohama, Japan
In-house administration number: DC67965
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R1-0 2021.7.21