Description

The FOLYSIL 2-WAY FOLEY catheter, crafted by Coloplast, is a high-quality medical device designed for effective urinary management. Made from 100% silicone, this catheter is both biocompatible and latex-free, ensuring safety for patients with latex sensitivities. Its primary function is to provide reliable bladder drainage through urethral or suprapubic insertion, making it suitable for a wide range of patients, including adults and children.

Key Features

• Retention Balloon: The catheter features a 2-way design with double lumens, one for urine drainage and the other for balloon inflation. The retention balloon, located at the distal tip, is available in various volumes, ranging from 1.5 mL for pediatric use to 30 mL for adults, ensuring secure placement.
• Size Variability: Available in French sizes from 6 to 24, it accommodates different patient needs. Lengths vary between 25 cm and 41 cm, with specific versions tailored for male, female, and pediatric patients.
• Tip Configurations: The catheter offers multiple tip types, including straight, Tiemann, and others, to facilitate easier insertion in diverse clinical scenarios.

Design and Visibility

• Radiopaque Stripe: A radiopaque stripe enhances visibility under X-ray, aiding in accurate placement.
• Surface Options: The shaft may be smooth or grooved, depending on the variant, to suit specific medical requirements.
• Drainage Eyes: Configurations include 1, 2, 4, or 6 drainage eyes, optimizing urine flow and reducing blockage risk.

Packaging and Sterility

Each catheter is ethylene oxide sterilized and comes in double sterile packaging with a peel-open pack, ensuring hygiene and convenience. Typically, they are available in single packs or boxes of five, with some versions including prefilled or empty syringes.

Intended Use

The FOLYSIL 2-WAY FOLEY catheter is intended for short-term and long-term use, ranging from a few weeks up to 12 weeks. It is suitable for:

• Bladder drainage in both normal and challenging catheterization cases.
• Bladder instillation with physiological saline solution.

Safety and Professional Use

Healthcare professionals should note that the balloon must be inflated with sterile water only. The device is contraindicated for patients with known allergies to its materials unless confirmed as a silicone-only version. Potential complications include bladder irritation, infection, and catheter migration, emphasizing the need for professional handling.

Regulatory Compliance

This catheter meets stringent regulatory standards, classified as a Class II medical device in both the US and EU. It is CE marked and complies with ISO 10993-1 and ISO 20696:2018 standards, ensuring high quality and reliability in clinical settings.