ARGON SKATER Drainage Catheter Locking and Non-Locking Pigtail Instruction Manual

ARGON SKATER Drainage Catheter Locking and Non-Locking Pigtail Instruction

Manual

SKATER™ Drainage Catheter Locking and Non-Locking Pigtail

Intended Use/Purpose

The SKATER™ Drainage Catheter is used for fluid drainage procedures.

Device Description

The SKATER™ Drainage Catheters are made of soft polyurethane for optimal kink- resistance and configuration memory. The catheters are coated with SLIP-COAT™ hydrophilic coating for minimal friction during insertion.

Indication for use

The product is for drainage of cysts, abscesses, pleural exudates, ascites, gall bladders and nephrostomies.

Duration

Up to 12 weeks

Warnings

• This device was designed, tested and manufactured for single use only. Reuse or reprocessing has not been evaluated and may lead to its failure and subsequent patient illness, infection or other injury. Do not reuse, reprocess or re-sterilize this device.
• Inspect the package integrity before use.
• Do not use if package appear open or if the expiry date has been exceeded.
•  During insertion, avoid contact with bone, cartilage, and scar tissue which can damage the catheter tip.

Caution (Locking Pigtail)

If the catheter is to be removed in another department, we recommend that these guidance notes accompany the patient’s case notes to ensure that the relevant personnel are aware of the presence of a locking catheter. It is also advisable to inform the patient.

Precaution

• The product must only be used by licensed, knowledgeable physician and qualified personnel who are familiar with the technique and who can ensure that patients will be monitored and appropriately treated for expected complications.
• Ensure the drain is secured and the system is intact to prevent dislodgement. Secure with a catheter fixation device, suture, or tape.
• Assess drain insertion site for signs of leakage, redness, or oozing. These signs may indicate an infection or irritation of the surrounding skin.
• Monitor changes in character or volume of fluid or bleeding.
• It is recommended affixing the catheter in a straight line and that any curvature be applied to the connecting tube.
• The drain also provides a pathway for bacteria to get into the wound. The risk of infection can be due to ascending bacterial invasion, foreign body reaction, decreased local tissue resistance, bacterial hiding places, poor placement due to kinked drain, and poor postoperative management.
• It is recommended that the physician follow the hospital’s standard of care procedures for drainage catheters.
• As with any draining procedure, there is risk of infection, pain, discomfort, inadvertent tissue damage, and fluid loss. When used as intended by a physician, the benefits of using the SKATER™ Drainage Catheter outweigh the risks associated with the use of the device.

Preparation

• Advance the straightener carefully over the curvature of the catheter, while straightening the curvature with your fingers.
• Locking Pigtail – Gently pull the thread to avoid unintentional looping of the thread.
• Introduce the chosen stiffener (if plastic: activate the hydrophilic coating with saline) and fasten the stiffener onto the catheter (Luer Lock).
• Remove the straightener
• Activate the coating by saline.

Procedure

• Advance the catheter over the guidewire that has been introduced into the patient using standard technique.

• When the catheter tip is inside the cavity, loosen the stiffener.

• Hold the stiffener tight and advance the catheter over the stiffener until the complete length of the pigtail is in the cavity.

• Non-Locking Pigtail
  1. Remove the stiffener.
  2. Verify correct position of the catheter using fluoroscopy.
  3. Remove the guidewire
  4. Connect the catheter to a drainage bag using a suitable connecting tube.

• Locking Pigtail
  1. Remove the stiffener and the guidewire.
  2. Gently pull the thread to ensure correct position and to complete curvature of the pigtail.
  3. Fix the thread tightly by winding it around the slot in the hub and finish by pressing the clip onto the slot and twist off the handle from the clip.

4. Connect the catheter to a drainage bag using a suitable connecting tube.
   5. Verify correct position of the catheter using fluoroscopy.

Removal of catheter

• Disconnect the drainage bag connector tube from catheter.
• Pigtail Catheter – Remove the clip and unwind the suture. Check that both threads are loose and cut one thread in order to loosen the pigtail.
• Pull the catheter out gently. If access is to be maintained, a straight floppy tip guidewire passed through the catheter will facilitate removal while maintaining access.

Disposal

After use, handle and dispose in accordance with hospitals policies and procedures concerning biohazard materials and waste.

Storage

Store in controlled room temperature.

NOTE: In the event a serious incident related to this device occurs, the event should be reported to Argon Medical at [email protected] as well as to the competent health authority where the user/patient resides.

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References

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

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