Tierrett PEG Kit
Instructions for use
Contraindicated to re-use[WARNINGS]<Using method>[1] This product is a medical device for endoscopic gastrostomy. Perform theprocedure while checking with an endoscope.
[There is a risk of damage to the organs and posterior wall of thestomach and accidental puncture.][2] After insertion, confirm with an endoscope that the bumper is properly
placed in the stomach.
[If nutritional supplements are administered in the wrong indwelling state,
there is a risk of causing serious complications such as peritonitis due toleakage into the abdominal cavity.][3] There should be no pressure on the gastric mucosa or skin due to excessivepulling of the catheter.
[There is a risk of buried bumper syndrome.][CONTRAINDICATIONS・PROHIBITION]
Do not reuse the product (single use only).
<Applicable target (patients)>
Do not apply in the following cases as a risk of adverse events.
[1] Patients whose stomach wall is not in contact with the abdominal wall.
[2] Patients with granulation tissue, infection or inflammation around thefistula.
[3] Patients with intense physical activity.
[Shape, structure, principle]
This product is sterilized with ethylene oxide gas.
・The connection 2 port adapter is used polyvinyl chloride (plasticizer: di(2-ethylhexyl) phthalate).
・This product (tip wire, puncture needle, loop wire, small incision scalpel) isused metal.

No①②③④⑤⑥⑦⑧⑨⑩⑪Component
PULL method PEG bumper catheter
Compact fixing plateConnection 2 port adapter
Clamp
Introducer cannula with inner needle (14 G)
Loop wire (PULL type)
Drape
Small incision scalpel (No.11) safe type
Syringe 10 mL
Gauze
Disinfection sponge①PULL method PEG bumper catheter
Tube O.D.
Tube I.D.
Size(A)(B)
16Fr
φ5.3mm
φ3.0mm20Fr
φ6.7mm
φ4.2mmEffective
length (C)
700mm
700mm

Quantity
11111111111

Bumperdiameter (D)
φ21.5mm
φ25.0mm<Raw Materials>①PULL method PEG bumper catheter: Silicone, ABS, SUS②Compact fixing plate: Silicone③Connection 2 port adapter: PVC, PP④Clump: PP⑤Introducer cannula with inner needle (14 G): SUS, PP, FEP/BaSO4, PE⑥Loop wire (PULL type): SUS(Nylon coating)⑦Drape: Paper, PE⑧Small incision scalpel (No.11) safe type: ABS, stainless⑨Syringe 10mL: PP, butyl rubber⑩Gauze: Cotton⑪Disinfection sponge: ABS, PU<Shape>①Body tube

DBumper
264108121416CMA**Fr

Tip wire

CLINY

Tip dilator

B
C：(Effective length)③②④Connection
2 portConnection
connector
Puncture cannela⑤Cap
Puncture Puncture cannula
needlePuncture needle hub

⑥⑦⑧

3

⑩⑪8

1011cc

69547

32

1⑨

<Principles>
The PULL method PEG catheter which forms the gastrostomy is secured by abumper in the stomach and a compact fixing plate on the abdominal wall.
[Intended purpose, efficacy or effect
Used for nutritional administration by gastrostomy in cases such as oral tumors
and pharyngeal tumors that require urgent nutritional administration.
[Operating or using method]
The below is a general procedure.
<Placement method>[1] The endoscope is inserted into the stomach according to the prescribed procedure.
[2] The stomach is sufficiently inflated by insufflation, and the skin at theposition where the transmitted light is strongest in the irradiated gastriccurvature is pressed. The appropriate gastrostomy site is determined byendoscopically confirming the ridge of the gastric cavity.
[3] A snare is inserted through the endoscopic channel and waits in the stomach.
[4] Make a skin incision at the appropriate location using a small incision
scalpel. (Make a skin incision of at least 1 cm.)
[5] An introducer cannula with an internal needle is inserted through the skin incision
site, after confirming the arrival in the stomach with an endoscope, the punctureneedle is removed.
[6] Insert the loop part of the loop wire from the puncture cannula into the stomach
and pull out of the oral cavity together with the endoscope while firmly grasping
the loop wire with the snare.
[7] When the loop wire is pulled out sufficiently, remove the snare and connect thetip wire of the catheter to the loop wire.
[8] After applying lubricant to the catheter, hold the loop wire coming out of theincision site, pull the catheter into the oral cavity by pulling slowly. After passing
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through the esophagus and into the stomach, pull out of the body together withthe puncture cannula from the incision site. At that time, do not pull it forcibly
and pull out with putting your hand lightly.
[9] When the catheter bumper touches the anterior wall of the stomach lightly,
reinsert the endoscope and check that it is properly placed.
[10] A compact fixing plate is passed through the tip of the catheter and fixed at theincision site.
[11] Cut the catheter vertically, leaving a length suitable for nutrition. Attach theconnection 2-port adapter to the cut end.
<Removal method>
Endoscopic removal method (recommended method)[1] Remove the compact fixing plate and slide it from the abdomen.
[2] The endoscope is inserted into the stomach according to the prescribed
procedure.
[3] Check if the bumper can be held by insufflating air.
[4] While checking if the catheter has adhered to the fistula, turn slowly and push
into the stomach by about 1 to 2 cm.
[5] Insert the snare and firmly hold the bumper.
[6] After disconnecting the catheter near the skin on the body surface, the bumper
held with the endoscope is pulled out of the oral cavity.

[The catheter may be pulled into the intestine and cause ileus.]
Adverse events
The following adverse events may be caused by the use of the product:
・Peritonitis
・Accidental puncture into other organs
・Stomach bleeding
・Pyloric stenosis
・Small bowel obstruction
・Gastric ulcer
・Wound infection
・Granulation[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.

<Precautions for the using method>[1] Make sure to flush with lukewarm water before and after nutritionaladministration.
[It is necessary to prevent catheter clogging due to accumulation of residues
such as nutritional supplements.][2] Note that administration of powdered medicine, etc. (especially drugs
containing binders, etc. as additives) via the catheter may clog the catheter.
[3] If it felt resistance when administering nutritional supplements or flushing withlukewarm water, etc., stop the operation.
[If the catheter lumen may be obstructed and the operation is continued without
clearing the obstruction of the catheter lumen, the internal pressure of thecatheter may rise excessively and cause damage or rupture.][4] Please note the following when performing the operation to clear the catheter
blockage.
・Use a syringe with a large capacity.
[Injectors with volumes smaller than 10 mL have higher injection pressure
and are more likely to break or rupture the catheter.]・Do not use stylets, etc.
・If the catheter is still clogged after performing the procedure, remove thecatheter.

< Expiration date >See the expiration date given on each package provided that the device isstored appropriately.
[By self-authentication (our data).]< Expiration date >This product has developed as "use within 90 days".
[By self-authentication (our data).]

Manufacturer
CREATE MEDIC CO.,LTD.
2-5-25 Chigasakiminami, Tsuzuki-Ku, Yokohama, Japan
In-house administration number: DC67891

R0-0 2020.10.29[Precautions]<Important basic caution>[1] Do not pinch the device with forceps too strongly.
[The tube may be broken or lumen may be occluded.][2] During use, regularly check for damage to this product, loose joints, leaks, etc.
[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 connection 2 port adapter.]<Failures・Adverse events>
Failures
The following failures may be caused by the use of the product:[1] Bumper disconnection.
[May cause ileus.][2] Deformation and rupture of tube
[Rupture by the following causes]
・Damage caused by handling during insertion (damage caused by forceps,
scissors, knife, other apparatuses)
・Other complex causes caused by the above events.
[3] Accidental or natural removal.
[Accidental or natural removal by the following causes]
・A patient with intense physical activity.
・Other complex causes caused by the above events.
[4] Leakage of nutrients from around the gastrostomy.
[5] Catheter position movement or out of position.
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