Cook Medical G55442 - CATHETER, SIL, BARTHOLIN, BLLN, J-BGC-015055, 5/BX
Word Catheter Silicone Bartholin Gland Balloon Set
The Word Catheter Silicone Bartholin Gland Balloon is used for the treatment of abscesses and cysts of the Bartholin gland. The balloon can be used in an office-based procedure. After being inserted into the area of the duct orifice and inflated with saline, the balloon can remain in place up to 28 days as the surgically created tract heals.
- Set components may vary
- Silicone Balloon Catheter
- Syringe
- Scalpel
| Order Number | Reference Part Number | Uninflated Catheter Fr | Balloon Volume (mL) | Quantity |
| G55442 | J-BGC-015055 | 15.0 | 3 | 5 |
Intended Use
Used for treatment of abscesses and cysts of the Bartholin gland.
Precautions
- Do not exceed the maximum 3ml inflation volume for this balloon device.
- Do not use petroleum based ointments or lubricants since they may damage silicone and burst balloon.
- Epithelization time may vary depending on each patient. The Word Catheter-Silicone Bartholin Gland Balloon is not intended to be left indwelling for periods of time greater than twenty-eight (28) days.
Warnings
- Always inflate the balloon with a sterile liquid. Never inflate with air, carbon dioxide or any other gas.
- Do not overinflate. Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.
- Consider underlying malignancy in women over age 40 who present with Bartholin Gland cysts or abscessses.
Instructions for Use
Word Catheter Silicone Bartholin Gland Balloon Set:
- Clean the area around the Bartholin gland with an antiseptic solution.
- Use the enclosed scalpel to drain the abscess and break up any loculi by making an incision in the outer wall of the cyst, preferably inside the hymenal ring. (A)
- After the abscess has drained, insert the deflated balloon through the incision and into the cyst. (B)
- Use the enclosed syringe to inflate the balloon with sterile saline until the balloon is sufficiently anchored in the cyst. (Do not exceed an inflation volume of 3 mL.) (C)
- Remove the syringe, leaving the inflated balloon in the cyst. Place the free end of the catheter inside the vagina. (D)
- After the new orifice has completely healed, deflate the balloon with a sterile syringe and remove the catheter.
Note: Healing time may vary with each patient. The Word catheter is not intended to be left indwelling for more than 28 days.
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 |
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.
