Cooper Surgical 19610 - Gynecath Uterine Infusion Catheter, 5 Fr, 10/CS

Cooper Surgical 19610 - Gynecath Uterine Infusion Catheter, 5 Fr, 10/CS

Cooper Surgical 19610 Gynecath Uterine Infusion Catheter

The GyneCath Uterine Infusion Catheter is a minimally invasive device used to help identify causes of abnormal uterine bleeding or infertility. GyneCath is designed for use in saline-infusion hysterosonography and water-based hysterosalpingography. The product comes in three variations to suit your practice needs, including catheters only, procedure tray sets with catheters, and procedure tray sets with no catheter.

GyneCath is designed for use in saline-infusion transvaginal ultrasound and in radiologic exams using water-based contrast media. Once the balloon is inflated and fluid infused, the clinicians view of the uterine cavity and fallopian tubes is significantly enhanced.

Two sizes available:

• 5 French for non-parous patients
• 7 French for previously pregnant patients

Available in tray sets for clinician convenience.

Cooper Surgical 19610 Gynecath Uterine Infusion Catheter Features and Benefits Comfortable A soft, flexible, minimally invasive catheter minimizes discomfort during uterine exams The flexible plastic catheter, and latex-free balloon are gentle on delicate tissues Easy to control Singlehanded catheter control Once catheter is placed, there is no need for further manipulation Significantly reduces the need for a metal tenaculum Easy to use Sliding plastic sheath aids in catheter placement Latex-free balloon inflates easily once catheter is placed Balloon reduces fluid leakage, allowing optimal diagnostic viewing Available in a tray set to facilitate procedures

Cooper Surgical 19610 Gynecath Uterine Infusion Catheter Intended Use/Indications

For administering contrast media during Hysterosalping-ography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, or patency of fallopian tubes.

Cooper Surgical 19610 Gynecath Uterine Infusion Catheter Contraindications

Suspected infection, suspected pregnancy, profuse bleeding or sexually transmitted disease.

Cooper Surgical 19610 Gynecath Uterine Infusion Catheter Precautions

Do not exceed the recommended balloon inflation volume of 1.5cc (5F catheter) or 3.0cc (7F catheter) or the balloon may burst.

The use of OIL-BASED contrast media such as ethyl esters may interact with the balloon of the catheter, causing rupture. The use of oil-based contrast media is not recommended.

Instructions for Use of Cooper Surgical 19610 Gynecath Uterine Infusion Catheter

Catheter Preparation

• Step 1: Grasp the translucent insertion sheath connected to the trapezoidal hub.
• Step 2: Remove and discard the crimped yellow protective cover, exposing the balloon catheter tip.
• Step 3: Test the balloon integrity by inflating with air, saline or water using the syringe in the set. If performing Hystero-sonography remove as much air as possible from the balloon. Deflate completely by pulling back on the syringe plunger and closing the stopcock.
• Step 4: Attach a contrast media-filled syringe (not supplied) to the blue luer hub and fill the catheter with contrast media to expel air. Advance the insertion sheath so that the distal end of the catheter protrudes slightly from the distal end of the sheath.

Catheter Placement

• Step 5: Visualize the external cervical os with the aid of a speculum and advance the sheath and catheter so that the tip of the catheter enters the cervical canal.
• Step 6: Hold the sheath stationary and advance the catheter into the cervical canal and into the uterine cavity.
• Step 7: Open the stopcock and slowly inflate the balloon with up to 1.5cc (5F catheter) or 3.0cc (7F catheter) of air, saline or water. Turn the stopcock off allowing the balloon to remain inflated.
• Step 8: Withdraw the catheter until it occludes the internal os of the cervix.

Injection of Contrast Media

• Step 9: Inject the contrast media, close the clamp and complete the study in a routine manner.
• Step 10: Occasionally, when access to the uterine cavity is difficult the balloon must be inflated within the endo-cervical canal.

Catheter Removal

• Step 11: Open the stopcock and deflate the balloon by pulling back on the syringe plunger. Withdraw the catheter.

Device Characteristics of Cooper Surgical 19610 Gynecath Uterine Infusion Catheter

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No