Cook Medical G46190 - CATH, GOLDSTEIN SONOBIOPSY, 7.2FR 26CM, 10/BX

Cook Medical G46190 - CATH, GOLDSTEIN SONOBIOPSY, 7.2FR 26CM, 10/BX

Goldstein SonoBiopsy Catheter

The Goldstein SonoBiopsy Catheter is used to access the uterine cavity for sonohysterography and to obtain an endometrial biopsy, if indicated, utilizing the same device. The device is a single catheter designed to perform saline infusion sonohysterography then, if indicated, a biopsy of the endometrium using the same device. Intended for one time use.

• The adjustable acorn-shaped positioner maintains catheter placement while reducing leakage of instilled saline at the external cervical os.
• Ink marks in 1 cm gradations up to 10 cm indicate catheter positioning.
• The catheters 7.2 French size allows it to pass into the uterus for tissue collection.
• The catheters round, closed tip eases cervical passage.
• The large oval sideport facilitates instillation of saline solution and aspiration of endometrial tissue.

Improve the visualization of the uterine cavity and obtain an endometrial biopsy

The Goldstein SonoBiopsy Catheter allows physicians to perform both sonohysterography and endometrial biopsy in one procedure. This specially designed catheter has a round, closed tip that may make it easier to access the uterus, and has a wide sideport that facilitates the transition between the instillation of saline solution and the aspiration of endometrial tissue.

Sonohysterography

Wide sideport facilitates saline instillation.

SonoBiopsy Catheter

The Goldstein SonoBiopsy Catheter is conveniently marked in 1 cm gradations up to 10 cm to indicate proper positioning. The catheter also features an adjustable acorn-shaped positioner that fits snugly into the cervical os, minimizing leakage.

Contraindications

This device should not be used in the presence of an active pelvic infection, acute pelvic inflammatory disease, a blood clotting disorder, sexually transmitted disease, history of uterine perforation, recent cesarean section, or active or suspected pregnancy.

Possible Risks Associated with Use of The Device

Adverse reactions to uterine procedures may include uterine perforation, infection, pain and cramping, uterine spasm, vasovagal syncope, and vaginal bleeding.
NOTE: Sterile if package is unopened or undamaged. Do not use if package is broken.

Suggested Instructions for Using The Goldstein Sonobiopsy Catheter

• Prefill catheter with sterile saline using a 10 ml Luer lock syringe.
• With cervix exposed, insert catheter through cervix into uterus taking care not to perforate the uterus.
• While holding the catheter steady, advance the positioner along the length of the catheter using forceps and occlude the external cervical os taking care not to perforate the uterus.
  NOTE: Reference ink marks on catheter may be used to aid in positioning of device.
• Instill saline through catheter into uterus.
• 5. Perform ultrasound procedure.
  NOTE: If no endometrial biopsy is indicated at this time, remove catheter 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.
• If an endometrial biopsy is indicated, aspirate residual saline in uterus using gentle suction with syringe.
• With catheter still in uterus, remove syringe and replace with a 10 ml Luer lock syringe.
• If catheter is not in fundus of uterus, re-advance catheter to fundus.
• Apply suction using the attached syringe, rotate catheter, and extract catheter from uterus.
• Transfer endometrial tissue specimen into appropriate receptacle for later cytological evaluation.
  NOTE: If insufficient amount of tissue has been obtained on first suction/extraction, catheter may be re-introduced and additional samples may be obtained by repeating steps 7-10.

CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician. This device should only be used by an experienced clinician skilled in performing uterine procedures.