ARGON MEDICAL DEVICE SKATER Introducer Biliary Drainage Kit Instruction Manual

SKATER Introducer Biliary Drainage Kit

Instruction Manual

Intended Use/Purpose

The SKATER™ Introducer Biliary Drainage Kit, Locking is intended for percutaneous biliary drainage via the Seldinger technique.

Device Description

SKATER™ Introducer Biliary Drainage Kit consist of fine trocar needle, access guidewire and co-axial dilator that provides atraumatic placement for 0.035” or 0.038” guidewire. The product features a large oval drainage holes and large lumen for maximal drainage capacity.

Indication for use

The product is for biliary drainage.

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.
• Do not continue to use if any of the component are damaged during the procedure.
• Introducer needle has a hub to help prevent finger from contacting/pulling wire. Do not pull Guidewire through needle.

Precautions

• The product must only be used by qualified personnel who are familiar with the technique.
• 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™ Introducer Biliary Drainage Catheter outweigh the risks associated with the use of the device.

Preparation

• Replace line with flush catheter and straightener with sterile saline.
• Advance the straightener carefully over the curvature of the catheter, while straightening the curvature with your fingers.
• 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 with saline.

Procedure

• Select and prepare the drainage site using standard technique.
• Perform the skin incision under local anaesthesia.
• Perform a fine needle puncture using ultrasound or X-ray.
• When correctly positioned remove the stylet and introduce the 0.018” guidewire.
• Remove the needle and dilate with the assembled dilator system.
• Loosen the inner catheter (coloured hub from white) checking that the tip of the outer dilator has been placed inside the cavity (note the radiopaque ring marker).
• Remove the inner dilator.
• Introduce a 0.035″ guidewire.
• Remove the outer dilator and withdraw the thin guidewire.
• Dilate the tract, if necessary.
• Advance the catheter over the guidewire in fluoroscopy.
• When the catheter tip is inside the biliary tree, loosen the catheter from the (metal or plastic) stiffner and advance the catheter over the guidewire as far as the duodenum. (Metal stiffner is used when placing a new initial drain. Plastic Stiffner is used when replaceing existing drain).
• The radiopague marker indicates the last side hole and must be positioned in the biliary passage.
• Remove the stiffener and the guidewire.
• Gently pull the thread to ensure correct position and to complete curvature of the pigtail.
• 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.
• Connect the catheter to a drainage bag using a suitable connecting tube.
• Verify correct position of the catheter using fluoroscopy.

Removal of catheter

• Disconnect the drainage bag connector tube from 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.

Possible Complication:

• Leakage
• Tract Infection
• Allergic reaction
• Temporary pain or discomfort
• Infection
• Bleeding
• Nontarget Puncture
• Hemorrhage
• Sepsis

Caution
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.

Disposal

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

Storage

Store at controlled room temperature.

NOTE: In the event a serious incident related to this device occurs, the event should be reported to Argon Medical at quality.regulatory@argonmedical.com as well as to the competent health authority where the user/patient resides.

ARGON MEDICAL DEVICES, INC.
1445 Flat Creek Road
Athens, Texas 75751 USA
Tel: +1 (903) 675 9321
Tel: +1 (800) 927 4669
www.argonmedical.com

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