Indication for use
The product is for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy and abscess).
Warnings
• This device was designed, tested and supplied sterile and is intended for single use only. Do not re-sterilize.
• Do not reuse or reprocess this device. Reuse or reprocessing has not been evaluated and may lead to its failure and subsequent patient illness, infection or other injury.
• Inspect the package integrity before use.
• Do not use if package is open or damaged, or if the expiration 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.
Precautions
• 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™ All-Purpose and Nephrostomy Drainage Set 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 lock the pigtail in order to avoid unintentional looping of the thread.
• For Single-Step:
1. Introduce the metal stiffener fully with the trocar needle slightly drawn back to avoid damaging the catheter wall.
2. Fasten the stiffener onto the catheter and introduce the trocar needle. Support the tip of the catheter advancing the needle. Snap the Choice Lock™ onto the stiffener hub. NOTE: 35, 45, and 60cm devices are not provided with a trocar needle and must be placed over the wire. Guidewire not included.
• For Over the Wire:
1. Introduce the chosen stiffener and fasten the stiffener onto the catheter (Luer Lock). NOTE: The flexible stiffener included with 45 and 60cm devices is coated. Activate the coating with saline prior to use.
• Remove the straightener and the catheter is now ready for use.
• Activate the catheter coating by saline.
