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Cook Medical G48149 - BALLOON, RIPENING, CERVICAL, 18FR, 10/BX
Cervical Ripening Balloon
The Cook Cervical Ripening Balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction. Please refer to the Instructions for Use for complete information on product usage, proper indications, and contraindications. Sold in boxes of 10.
|Order Number||Reference Part Number||Catheter Fr||Length (cm)||Balloon Volume (mL)|
The Cook Cervical Ripening Balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction.
- Patient receiving or planning to undergo exogenous prostaglandin administration
- Placenta previa, vasa previa, or placenta percreta
- Transverse fetal orientation
- Prolapsed umbilical cord
- Prior hysterotomy, classic uterine incision, myomectomy or any other full-thickness uterine incision
- Pelvic structural abnormality
- Active genital herpes infection
- Invasive cervical cancer
- Abnormal fetal heart-rate patterns
- Breech presentation
- Maternal heart disease
- Multiple gestational pregnancy
- Presenting part above the pelvic inlet
- Severe maternal hypertension
- Any contraindication to labor induction
- Ruptured membranes
|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|
|Prescription Use (Rx):||Yes|
|Over the Counter (OTC):||No|
|Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):||No|
If fetal membranes rupture spontaneously while this device is in place, it is recommended that both balloons be deflated and the device removed in preparation for spontaneous active labor contractions.
Potential Adverse Events
Risks associated with use of the Cook Cervical Ripening Balloon and labor induction may include, but are not limited to:
- Placental abruption
- Uterine rupture
- Spontaneous rupture of membranes
- Spontaneous onset of labor
- Device expulsion
- Device entrapment and/or fragmentation
- Maternal discomfort during and after insertion
- Failed dilation or need for caesarean delivery
- Cervical laceration
- Risk of pre-term labor and birth in subsequent pregnancy
Instructions for Use
- Advance the Cervical Ripening Balloon through the cervix until both balloons have entered the cervical canal. (1)
- Inflate the uterine balloon with 40 mL of saline. Once the uterine balloon is inflated, pull the device back until the balloon abuts the internal cervical os. (2)
- You should see the vaginal balloon outside the external cervical os. Inflate the vaginal balloon with 20 mL of saline. (3)
- Once the balloons are situated on either side of the cervix, add salinea maximum of 80 mL per balloon. Time the placement of the balloon so that it is in place no longer than 12 hours before active labor is induced. (4)
Deflate both balloons through the corresponding valves marked U and V and remove vaginally. NOTE: If the membranes rupture spontaneously before removal of the device, it is recommended to deflate the balloons and remove the device to facilitate active labor management.
- Concomitant use of the Cook Cervical Ripening Balloon with exogenous prostaglandins may increase the risk of adverse events associated with prostaglandin administration, including, but not limited to: uterine hyperstimulation, impaired utero-placental circulation, tachysystole, uterine rupture, placental abruption, amniotic fluid embolism, pelvic pain, retained placenta, severe genital bleeding, shock, fetal bradycardia, fetal death, and maternal death.
- The product should not be left indwelling for a period greater than 12 hours.
- The safety and effectiveness of the Cook Cervical Ripening Balloon has not been established among women with an obstetrical history of low transverse caesarean section.
- The safety and effectiveness of extra-amniotic saline infusion with the Cook Cervical Ripening Balloon has not been established.
- If spontaneous rupture of membranes occurs while the Cook Cervical Ripening Balloon is in place, there is a risk that the uterine balloon could become entangled in the umbilical cord, necessitating emergent cesarean delivery.
- Always inflate the balloon with a sterile saline. 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.
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).