Cook Medical COKG18664 - Goldstein Sono Catheter 5.2fr 10/BX

Cook Medical COKG18664 - Goldstein Sono Catheter 5.2fr 10/BX

Overview of the Cook Medical COKG18664 - Goldstein Sono Catheter 5.2fr

The Cook Medical Goldstein Sono Catheter (COKG18664) is a specialized medical device designed primarily for use in gynecological procedures, especially for uterine manipulation during sonohysterography and other diagnostic or therapeutic interventions. The catheter has a French size of 5.2fr, which refers to its diameter, making it suitable for minimally invasive procedures. The catheter is designed for ease of use, providing accurate diagnostic visualization and manipulation capabilities.

Design Features:

• Diameter: 5.2 French (Fr), which ensures comfort during insertion and is ideal for uterine procedures.
• Balloon Tip: The catheter is equipped with an inflatable balloon tip that helps to anchor the catheter in place within the uterus for precise positioning during procedures.
• Single-use and sterile: Ensures hygiene and minimizes infection risks. It is packaged in sterile conditions and is intended for one-time use.
• Soft flexible material: Made from biocompatible materials, designed to minimize discomfort and trauma during insertion and manipulation.

Intended Use in Medical Settings

The Goldstein Sono Catheter is primarily used in gynecological settings, with common applications including:

• Sonohysterography (SHG): This diagnostic procedure uses the catheter to introduce saline into the uterus while performing an ultrasound, allowing for detailed visualization of the uterine cavity. This helps in diagnosing conditions like uterine polyps, fibroids, and abnormalities in the uterine lining.
• Assisting with fertility procedures: The catheters precision allows for effective uterine manipulation, aiding fertility assessments or embryo transfers in assisted reproductive technologies (ART).
• Uterine diagnostics and treatment: It can be used to help position and manipulate the uterus during other diagnostic or interventional procedures, allowing doctors to examine abnormalities and proceed with treatments.

Certifications, Safety Standards, and Regulatory Approvals

The Goldstein Sono Catheter meets stringent FDA regulations and is approved for medical use. It also adheres to international ISO safety standards related to medical device manufacturing and biocompatibility. As a sterile, single-use product, it minimizes infection risks and meets healthcare requirements for hygiene and patient safety.

Comparison with Other Catheters

When compared to similar uterine manipulation catheters, the Goldstein Sono Catheter stands out for:

• Balloon stability: The balloon tip allows secure anchoring, which is an advantage over non-balloon catheters, offering better control during procedures.
• Small diameter: At 5.2fr, it offers a smaller diameter than many competitors, which may be more comfortable for patients, reducing discomfort during procedures.
• Ease of use: The flexible material and ergonomic design make it easier for physicians to insert and maneuver, compared to some other rigid catheters on the market.

Common User Profile and Typical Scenarios

The typical users of the Goldstein Sono Catheter include:

• Gynecologists who perform sonohysterography, fertility assessments, or other diagnostic uterine procedures.
• Fertility specialists who use the catheter for manipulation and visualization during ART procedures, such as embryo transfers.
• Radiologists who may use the catheter during ultrasound-based uterine assessments.

Typical scenarios include diagnostic imaging of the uterus for patients experiencing abnormal bleeding, recurrent miscarriages, or fertility challenges. The catheter is also ideal for positioning and manipulation during fertility treatments or minor surgical interventions within the uterus.

Best Practices for Use and Maintenance

For safe and effective use of the Goldstein Sono Catheter, follow these best practices:

• Ensure sterility: Only open the sterile packaging when ready for immediate use to maintain the catheter's integrity and avoid contamination.
• Patient comfort: Use a lubricant when necessary and handle the catheter gently to minimize discomfort during insertion.
• Balloon inflation: Inflate the balloon slowly and carefully to ensure proper positioning within the uterus without causing trauma.
• Single-use: Discard the catheter after a single use to prevent infection risks and cross-contamination.

By following these practices, healthcare professionals can ensure accurate diagnostic procedures while prioritizing patient safety and comfort.

Goldstein Sonohysterography Catheter

The Goldstein Sonohysterography Catheter is used to access the uterine cavity for sonohysterography. It is available in either PTFE or polyethylene material.

Used to access the uterine cavity for sonohysterography.

• The adjustable acorn-shaped positioner maintains catheter placement while reducing leakage of instilled saline at the external cervical os.
• The ink band provides a reference mark to indicate proper catheter positioning.
• The catheters round, closed tip eases introduction into the uterus.
• The large oval sideport facilitates instillation of saline solution.

Polyethylene

Contraindications

This device should not be used in the presence of hemorrhage, active pelvic infection, sexually transmitted disease, profuse bleeding, or pregnancy. This device should only be used by an experienced clinician.

Suggested Instructions for Using Goldstein Sonohysterography Catheter

• Pre-fill catheter with saline and remove syringe prior to placement. NOTE: Syringe is reattached after catheter is positioned.
• With cervix exposed, insert catheter into uterus using packing forceps. NOTE: Reference mark on catheter may be used to aid in positioning.
• Advance positioner into cervix using forceps.
• Instill saline through catheter into uterus.
• Catheter is removed upon completion of ultrasound procedure.
  NOTE: Upon removal of catheter, ensure that positioner is still on body of catheter. If still lodged in patient cervix, remove using forceps.