HSG Catheter

DEVICE DESCRIPTION: HSG Catheter – Rx Only

The HSG Catheter consists of a latex-free balloon catheter, insertion sheath and syringe. Does not contain natural rubber Latex components.

Intended Use/Indications:

For administering contrast media or saline during Sonohysterography and Hysterosalpingography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes.

Contraindications:

Suspected infection, suspected pre gnancy, profuse bleeding or sexually transmitted disease.

Precautions:

Do not exceed the recommended balloon inflation volume (1.5cc for the 5F catheter and 3cc for the 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 possible balloon rupture. The use of aqueous contrast media is recommended.

Adverse Events:

How Supplied:

Instructions for Use:

Remove catheter from pouch.
Remove and discard the yellow sleeve, exposing the balloon catheter tip.
Test balloon integrity: Inflate with air using the syringe, check for leaks, deflate, close stopcock.
Attach a contrast media or saline filled syringe (not supplied) to the luer connector. Inject contrast media or saline through catheter to remove air. Advance the insertion sheath so that the distal end of the catheter protrudes slightly from the distal end of the sheath.
View the cervix and advance the sheath and catheter so that the tip of the catheter enters the cervix.
Advance the catheter through the cervical canal and into the uterus.
Open the stopcock and slowly inflate the balloon with up to 1.5cc for the 5F catheter and 3cc for the 7F catheter of either air or saline.
Close the stopcock allowing the balloon to remain inflated. Gently withdraw catheter so balloon will rest against internal os.
Inject contrast media or saline into the uterus and complete the examination.
Open the stopcock and deflate the balloon. Withdraw the
catheter.

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