Cook Medical G24813 - CATHETER, UVUE HSG / SHG, J-UHSG-062026, 10/BX

Cook Medical G24813 - CATHETER, UVUE HSG / SHG, J-UHSG-062026, 10/BX

uVue HSG/SHG Catheter

The uVue provides, in one piece, the combined stiffness of a catheter and integrated sheath. With its malleable inner support stylet, uVue helps physicians achieve greater control with one-handed placement.

It is the first catheter of its kind to feature a balloon, inner stylet and integrated sheath in one product. Additionally, the uVue can be used to perform both hysterosalpingography (HSG) and sonohysterography (SHG) procedures.

• Malleable internal sylet is easily formed to any desired curve.
• Integrated sheath adds rigidity to aid in placement.
• Catheter design makes it possible to use with one hand.
• 3 mL syringe included.

Intended Use

The uVue HSG/SHG Catheter is intended to access the uterine cavity for sonohysterography (SHG), hysterosalpingography (HSG) and other diagnostic studies.

Contraindications

This device should not be used in the presence of hemorrhage, active pelvic infection, sexually transmitted disease, profuse bleeding, pregnancy, recent cesarean section, or if the patient currently has or suspects she may have an intrauterine device.

Device Characteristics

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":	No
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

Precautions

• This procedure should only be performed by a physician or properly licensed practitioner trained in diagnostic and interventional techniques. Standard techniques for SHG and HSG procedures should be employed.
• Use of the uVue HSG/SHG Catheter in postpartum patients or patients with a recent uterine perforation should be determined at the physicians discretion. Risk of uterine wall injury may be increased in these patients.

Instructions for Use Sonohysterography (SHG)

• Form the catheter to desired shape, if applicable.
• Position a vaginal speculum within the vagina so the external cervical os can be visualized during catheter insertion.
• Cleanse the cervix with an appropriate cleansing solution.
• Prime the catheter with saline.
• Insert the catheter tip through cervix and into the uterus.
• Fill the syringe with sterile saline solution. Eliminate air from the syringe.
• Inflate the balloon by instilling sterile saline solution and close the stopcock once desired volume is injected.
• Pull back gently on the catheter shaft to seat the inflated balloon against the internal cervical os.
• Inject sufficient medium through the catheter into the uterus.
• Perform ultrasound procedure.
• Deflate the balloon.
• Take a ultrasound final examination of the lower uterus.
• Remove the catheter from the cervix when examination is complete.

Instructions for Use Hysterosalpingography (HSG)

• Form the catheter to desired shape, if applicable.
• Position a vaginal speculum within the vagina so the external cervical os can be visualized during catheter insertion.
• Cleanse the cervix with an appropriate cleansing solution.
• Prime the catheter with medium.
• Insert the catheter tip through the cervix and into the uterus.
• Fill the syringe with sterile saline solution. Eliminate air from the syringe.
• Inflate the balloon by instilling sterile saline solution and close the stopcock once desired volume is injected.
• Pull back gently on the catheter shaft to seat the inflated balloon against the internal cervical os.
• Inject sufficient contrast medium through the catheter into the uterus.
• Perform fluoroscopic procedure.
• Deflate the balloon.
• Take a fluoroscopic final examination of the lower uterus.
• Remove the catheter from the cervix when examination is complete.

Warnings

• Always inflate the balloon with a sterile liquid. Never inflate with air, carbon dioxide or any other gas.
• Do not overinflate. Using excessive volume to inflate the balloon on this device can cause the balloon to rupture. Refer to product label or the inflation line on the balloon device for appropriate balloon volume.

How Supplied

Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure to light. Upon removal from the package, inspect the product to ensure no damage has occurred.

CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or a properly licensed practitioner).