ARGON 20-1100-07 SKATER Safety Centesis Catheter Instructions

Instructions for Use

20-1100-07 SKATER Safety Centesis Catheter

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****Argon Medical Devices, Inc.
1445 Flat Creek Road
Athens, Texas 75751 USA
Te l : +1 800-927-4669
Tel: +1 903-675-9321
www.argonmedical.com

Brasil Detentor da Notificação: Ecomed
Comercio de Produtos Médicos Ltda.
Endereço: Av. Augusto Severo, 156 – Lojas
A/ B – Glória – Rio de Janeiro/ RJ 20021-040
Notificação nº: 10337859012

SKATER™ SAFETY CENTESIS CATHETER with PIGTAIL and BLUNT RETRACTING STYLET

Intended Use:

The SKATER™ Safety centesis catheter with Pigtail and Blunt Retracting Sty let is intended for aspiration of fluid from the body. In thoracentesis, the fluid is removed from the pleural cavity. In paracentesis, ascitic fluid is removed from the peritoneal cavity.

Contraindications:

There are no absolute contraindications for thoracentesis. The absolute contraindication for paracentesis is acute abdomen that requires surgery. This tray should be used by a physician familiar with the possible side effects, typical findings, and limitations associated with thoracentesis or paracentesis procedures. The benefits of the procedure should always be weighed against the risk before the procedure is performed.

Cautions:

• Rx Only: Federal Law (USA) restricts this device to sale by or on the order of a physician. Read instructions prior to use.
• The Catheter was designed, tested and manufactured for single use only.
• Do not use the contents if package is open or damaged.
• Do not reuse, reprocess or re-sterilize. Reuse or reprocessing has not been evaluated and may lead to product failure and subsequent patient illness, infection, or other injury.
• Verify the integrity of the catheter components before use. If a component appears damaged, use a replacement catheter.
• In thoracentesis procedures fluid should be removed in stages not to exceed 1.5 L/day due to hypotension, pulmonary edema risks.
• Tighten all Luer connections.
• The air-lock valve is designed to minimize potential pneumothorax during centesis. Should the original configuration be changed, the valve sealing mechanism may no longer function.

Warnings:

• These instructions are NOT meant to define or suggest any medical or surgical technique. The individual practitioner is responsible for the proper procedure and techniques to be used with this device. Procedure must be performed by trained personnel.
• To avoid needle breakage, do not attempt to straighten a bent needle; discard and complete the procedure with a replacement needle.
• Do not reshield used needle.
• The following situation should be considered when doing procedures planning, and the clinician should proceed with caution:

Thoracentesis

• Uncorrected bleeding diathesis, coagulopathy, thrombocytopenia, or other bleeding disorders
• Altered chest wall anatomy or chest wall cellulitis at the puncture site
• Elevated INR
• Patient is under mechanical ventilation
• Uncertain fluid location by examination or minimal fluid volume
• Hemodynamic or respiratory instability
• Severe pulmonary disease that would make complications life threatening

Paracentesis

• Severe thrombocytopenia (platelet count < 20 x 10 3 /µL) and coagulopathy
• Coagulation disorders
• Pregnancy
• Distended intra-abdominal organs
• Abdominal wall cellulitis
• Intra-abdominal adhesions and surgical scars

Potential Complications:
Centesis procedures should not be attempted by physicians unfamiliar with the possible complications. Possible complication may include, but are not limited to the following:

Thoracentesis

• Iatrogenic pneumothorax
• Hemoptysis
• Postexpans ion pulmonary edema
• Hemothorax
• Pain, bleeding, cough, and infection
• Perforation or injury of organs
• Vasovagal syncope

Paracentesis

• Postparacentesis hypotension
• Persistent leakage of ascetic fluid
• Pain, bleeding complications, and infection
• Perforation or injury of organs

How Supplied:
The Catheter is supplied with or without an accessories tray. If using the accessories tray, consult the instructions for use associated with the tray. All components are sterilized by ethylene oxide gas and are intended for single use only. Do not use the device if package is open or appears to be damaged or defective. The device has no components made of natural rubber latex.

Preparation and Instructions for Use:

1. Prepare and position the patient for the procedure according to standard aseptic technique.
2. Slide the pigtail straightener to straighten the pigtail.
3. Load the blunt retracting stylet needle through the air lock valve of the pigtail catheter.
4. Confirm the needle bevel (blunt stylet and sharp needle point) extend beyond the distal catheter tip.
5. Remove pigtail straightener before inserting catheter assembly.
6. Use the scalpel to nick the skin.
7. Firmly hold the proximal hub and the distal tip of the catheter. Using the tip, puncture the skin and advance the catheter needle instrument using ultrasound or CT guidance.
8. Advance the catheter into the desired cavity. Fluid can be aspirated through the needle into a syringe to confirm placement. If diagnostic samples are  required, withdraw desired sample, close off the side port, remove syringe and expel fluid into specimen vials.
9. Once placement is confirmed, hold the catheter in place and pull out the needle.
10. A cap can be added to the air lock valve if high vacuum will be applied.
11. Position catheter according to physician judgement. Select one of the three drainage options below. Should a partial or complete occlusion occur, review the Catheter Occlus ion section below for suggested techniques to clear the obstruction.
12.  At completion of procedure, remove catheter quickly to prevent hydrostatic dysfunction, and cover puncture site with bandage.

Three Drainage Procedure Options:
Option 1: Manual Drainage Set

1. Attach patient drainage port (shortest length tubing) to side port of stopcock.
2. Connect drainage bag port to drainage bag.
3. Connect drainage syringe port to 60 ml syringe.
4. Tighten all connections with push-twist motion.
5. Turn stopcock flow control arm off to air lock valve to open side port.
6. Begin drainage procedure by slowly applying an alternating aspiration and injection motion with a 60 ml syringe.
7. Upon completion of drainage, turn the stopcock flow control off (sideport position) and remove the drainage tubing from the stopcock.
8. Quickly remove catheter from patient to avoid introduction of atmospheric air. Protect puncture site with a bandage.

Option 2: Vacuum Assisted Drainage

1. Attach male Luer end of vacuum bottle drainage tubing to side port of stopcock.
2. Tighten all connections with push-twist motion
3. Remove protector from needle and puncture vacuum bottle.
4. Turn stopcock off to air lock valve. This will start fluid flow into the bottle.
5. Upon completion of drainage, turn the stopcock flow control off (sideport position) and remove the drainage tubing from the stopcock.
6. Quickly remove catheter from patient to avoid introduction of atmospheric air. Protect puncture site with a bandage.

Option 3: Wall Suction Drainage

1. Attach male Luer end of vacuum bottle drainage tubing to side port of stopcock.
2. Remove and dispose of vacuum needle with protector and replace with 5-in-1 drainage adapter.
3. Tighten all connections with push-twist motion prior to proceeding.
4. Insert 5-in-1 adapter firmly into wall suction drainage tubing.
5. Start wall suction drainage and turn stopcock off to air lock valve.
6. Upon completion of drainage, turn the stopcock flow control off (sideport position) and remove the drainage tubing from the stopcock.
7. Quickly remove catheter from patient to avoid introduction of atmospheric air. Protect puncture site with a bandage.

Catheter Occlusions:
The following steps may help clear partial or complete occlusions. Repeat steps if necessary.

1. Wick the catheter back and forth
2. Advance 0.038” or 0.035” guidewire through the proximal hub of the catheter. Gently manipulate to clear the occlusion

Disposal:
After use, this product may be a potential biohazard. Handle in a manner which will prevent accidental puncture. Dispose in accordance with applicable laws and regulations.
Storage:
Store at standard ambient temperature.

© 2015 Argon Medical Devices, Inc.
20-1100-07
Date of Issue: 02/19/2024 Rev. C

References

• Argon Medical Devices | Interventional Solutions That Make a Difference
• Product Symbols | Medical Devices Symbols | Argon Medical Devices

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