MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-09-20 for COOK CERVICAL RIPENING BALLOON W/STYLET N/A J-CRBS-184000 manufactured by Cook Inc.
[120897615]
Common device name: catheter, balloon, dilation of cervical canal. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[120897616]
It was reported that a doctor had heard that two or three babies had changed position in the uterus after a j-crbs-184000 had been used. The doctor didn? T have much more information than this. As reported after follow up, the hospital has had two cases where the baby? S head changed position after using the j-crbs. The first case reported on this mfr. Report # 1820334-2018-02776 and second case is reported on mfr. Report # 1820334-2018-02777. The first case on (b)(6) 2017, "was a multiparous woman where the baby? S position was unstable (but the head was below the pelvic inlet) and the baby changed to transverse position after inserting j-crbs. They were not able to change it back to the right position and they had to perform a c-section. " additional patient and event information has been requested but has not been received at the time of this report. The instructions for use that accompanies the cook cervical ripening balloon with adjustable stylet contains the following contraindications, warnings, and potential adverse events: contraindications: 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 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, polyhydramnios, presenting part above the pelvic inlet, severe maternal hypertension, any contraindication to labor induction, ruptured membranes. Warnings: 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 stylet should only be used to traverse the tip of the catheter through the cervix and should be removed as soon as the uterine balloon is above the level of the internal uterine opening (internal os) prior to full insertion of the catheter. Aggressive insertion may result in injury to the baby. The product should not be left indwelling for longer 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 cesarean section. The safety and effectiveness of extra-amniotic saline infusion with the cook cervical ripening balloon has not been established. 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. 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 caesarean delivery. 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, bleeding, risk of pre-term labor and birth in subsequent pregnancy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02776 |
| MDR Report Key | 7894121 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-20 |
| Date of Report | 2019-02-20 |
| Date of Event | 2017-08-23 |
| Date Mfgr Received | 2019-02-15 |
| Device Manufacturer Date | 2017-03-28 |
| Date Added to Maude | 2018-09-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CERVICAL RIPENING BALLOON W/STYLET |
| Generic Name | PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA |
| Product Code | PFJ |
| Date Received | 2018-09-20 |
| Model Number | N/A |
| Catalog Number | J-CRBS-184000 |
| Lot Number | 7783756 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-20 |