ARGON MEDICAL DEVICES Skatertm Nephrostomy Catheter Instruction Manual

ARGON MEDICAL DEVICES Skatertm Nephrostomy Catheter

Product Information

Specifications

• Brand: SKATERTM Nephrostomy Catheter
• Manufacturer: Argon Medical Devices, Inc.
• Intended Use: Fluid drainage procedures for nephrectomies
• Features: Locking or non-locking pigtail, with metal or flexible stiffening cannula
• Coating: SLIP-COATTM hydrophilic coating at the distal tip
• Drainage Holes: Large lumen and large oval drainage holes
• Duration: Up to 12 weeks

Product Usage Instructions

• The SKATERTM Nephrostomy Catheter is specifically designed for fluid drainage procedures in nephrostomies.
• The catheter offers locking or non-locking pigtail options, with a choice of metal or flexible stiffening cannula.
• It is coated with SLIP-COATTM hydrophilic coating at the distal tip for easy insertion.
• The large lumen and oval drainage holes are designed to maximize drainage capacity.

Usage Instructions

1. Remove the stiffener from the catheter.
2. Verify the correct position of the catheter using fluoroscopy.
3. After verification, remove the guidewire.
4. Connect the catheter to a drainage bag using a suitable connecting tube.

Reporting Incidents

• In case of a serious incident related to the device, report the event to Argon Medical at quality.regulatory@argonmedical.com and inform the competent health authority where the user/patient resides.

FAQ

• Q: What is the intended use of the SKATERTM Nephrostomy Catheter?
• A: The catheter is used for fluid drainage procedures in nephrostomies.
• Q: How long can the catheter be used for?
• A: The catheter can be used for up to 12 weeks.

SYMBOLS

• The symbols glossary is located electronically at www.argonmedical.com/symbols.
• https://www.argonmedical.com/resources/product-information.

SKATER™ Nephrostomy Catheter – Locking and Non-Locking

Intended Use/Purpose
The SKATER™ Nephrostomy Catheter is used for fluid drainage procedures.

Device Description

• SKATER™ Nephrostomy Catheter offers a locking or non-locking pigtail, with a metal or flexible stiffening cannula.
• The product features SLIP-COAT™ hydrophilic coating at the distal tip for easy insertion, large lumen, and large oval drainage holes designed for maximal drainage capacity.

Indication for use
The product is for 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’s integrity before use.
• Do not use if the package appears 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 physicians 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 the 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 to affix 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 a risk of infection, pain, discomfort, inadvertent tissue damage, and fluid loss. When used as intended by a physician, the benefits of using the SKATER™ Nephrostomy Catheter outweigh the risks associated with the use ofthe 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

• Select and prepare the drainage site using standard techniques.
• Insert an appropriate guidewire using standard technique.
• Dilate the tract, if necessary.
• Advance the catheter over the guidewire in fluoroscopy.
• When the catheter tip is inside the renal pelvis, 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 the 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 the correct position and to complete the curvature of the pigtail.
3. Fix the thread tightly by winding it around the slot in the hub finish by pressing the clip onto the slot and twisting off the handle from the clip.
4. Connect the catheter to a drainage bag using a suitable connecting tube.
5. Verify the correct position of the catheter using fluoroscopy.

Removal of catheter

• Disconnect the drainage bag connector tube from the catheter.
• Locking Pigtail – Remove the clip and unwind the suture. Check that both threads are loose and cut one thread 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 of under hospital 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 quality.regulatory@argonmedical.com as well as to the competent health authority where the user/patient resides.

CONTACT

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

EMERGO EUROPE

• Westervoortsedijk 60
• 6827 AT Arnhem
• The Netherlands
• +31 70 345 8570

Emergo Consulting (UK) Limited

• c/o Cr 360 – UL International
• Compass House, Vision Park Histon
• Cambridge CB24 9BZ
• United Kingdom

References

• Argon Medical Devices | Interventional Solutions That Make a Difference

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