Description

The INTERVENTION URETERIC CATHETER is a specialized medical device designed for precise ureteral access and management. This single-use, sterile catheter is crafted to support various urological procedures, including ureter dilation, obstruction bypass, and upper urinary tract drainage or irrigation. Its versatile application extends to stone removal, retrograde urography, and effective management of urinary retention or obstruction.

Design Features

• Configuration: The catheter features a single lumen with a straight tip, complemented by graduated markings for accurate placement. The design includes a bevelled distal end with at least one lateral eye, enhancing functionality.
• Proximal End: Equipped with a straight cut and a removable Luer-Lock adaptor, allowing seamless syringe connection.
• Coating: Some variants may include a friction-reducing coating, and the catheter is radiopaque for enhanced imaging guidance.

Material Composition

Constructed from high-quality materials such as PVC, polyurethane, or silicone, the catheter offers latex-free options to accommodate allergy concerns. Hydrogel-coated variants are available to improve patient comfort and tolerance.

Size and Compatibility

Available in various diameters ranging from CH5 to CH7, with lengths approximately 70 cm, and some variants extending up to 120 cm. The catheter's guidewire compatibility varies by size, ensuring adaptability to specific clinical needs.

Packaging and Sterility

Each catheter is individually packaged in a peel-open pack to maintain sterility until use, adhering to stringent hygiene standards essential for medical environments.

Intended Patient Population

Suitable for both pediatric and adult patients, with size and tip type selection tailored to individual anatomical and clinical requirements. Proper insertion technique is crucial, with recommendations to use aseptic methods and confirm placement visually.

Usage Guidelines

Healthcare professionals are advised to secure the catheter appropriately, position drainage systems correctly, and select the smallest effective size to minimize trauma. Balloon inflation, if applicable, should only occur after confirming urine flow, using sterile water.

Maintenance Recommendations

Regular hygiene at the insertion site, minimizing system disconnections, and daily necessity assessments are recommended to reduce infection risks. Catheter changes should be limited to specific circumstances such as system breaches or detected infections.

Potential Complications

Possible complications include urethral injury, infection, and other urological challenges. Contraindications involve conditions like urethral stricture or trauma.

Compliance and Storage

The catheter complies with ISO 20697:2018 standards and holds a CE mark, classified as a Class IIb medical device under EU MDR. Storage should be below 30°C, away from sunlight and humidity.

Professional Use

Intended for use by healthcare professionals, with comprehensive instructions provided. In cases of home use, appropriate education for families may be necessary to ensure effective management.