MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-04-30 for COOK CERVICAL RIPENING BALLOON J-CRB-184000 manufactured by Cook Urological, Inc..
[2687591]
During the past year, this facility had three occasions where a pt's water broke while cook medical's cervical ripening balloon was indwelling. In each of these 3 instances, the attending ob deflated the balloons of the cervical ripening balloon and attempted to remove the catheter from the pt. In each of these reported instances, the umbilical cord was wrapped around the cervical ripening balloon when it was removed from the pt which prompted the attending db to perform an emergency c-section. The facility did not report these instances to cook at the time of the occurrence. I learned about them on (b)(4) 2012 during a meeting with the residency program dir, residents, and attending db's. The facility is not requesting any response from cook to address these repeated occurrences although i told them that our company would likely be in touch to try and learn more info about each of these 3 instances which occurred within the past year. The facility is still interested in using the cervical ripening balloon and is considering using the cervical ripening balloon with stylet. The sales rep has reported that the mothers and babies are fine following emergency c-section.
Patient Sequence No: 1, Text Type: D, B5
[9807857]
A complete investigation of the product cannot be performed as the product was discarded at the customer's facility. Initial investigation of the customer's comments have been inconclusive as when used correctly the balloon fits very tightly and contours to the cervical canal. We are currently unable to determine how the incident described by the customer has occurred. Our instructions for use warns that the balloon should be removed immediately if the amniotic membrane ruptures or labor begins. We have received no complaints from any other facility regarding this type of occurrence. Further investigation on the customer's comments is currently being conducted by cook clinical staff, ra, products managers, and the dr who invented the balloon catheter. Cook will forward add'l info to fda as it becomes available. It has been reported that caesarian section deliveries were performed and that there was no harm to the babies or mothers.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2012-00004 |
| MDR Report Key | 2560338 |
| Report Source | 05 |
| Date Received | 2012-04-30 |
| Date of Report | 2012-04-26 |
| Date Facility Aware | 2012-03-30 |
| Report Date | 2012-04-26 |
| Date Mfgr Received | 2012-03-30 |
| Date Added to Maude | 2012-05-07 |
| 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 | CHRIS KILANDER |
| Manufacturer Street | 1100 WEST MORGAN ST. |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CERVICAL RIPENING BALLOON |
| Generic Name | HDY DILATOR, CERVICAL |
| Product Code | HDY |
| Date Received | 2012-04-30 |
| Catalog Number | J-CRB-184000 |
| Lot Number | NA |
| 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 UROLOGICAL, INC. |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-04-30 |