MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-06-30 for COOK CERVICAL RIPENING BALLOON J-CRB-184000 manufactured by Cook Urological, Inc..
[20994249]
Customer states: we have had a recent maternal death most likely due to an amniotic fluid embolus. We are still waiting for the final autopsy report. She was being induced by the cervical ripening balloon which was placed the night before her induction. Can you do some research on this and let me know if the ripening balloon can be directly linked to afe. I know in the warning it states "concurrent use with the balloon and prostaglandins can cause afe. "
Patient Sequence No: 1, Text Type: D, B5
[21192485]
A proper eval cannot be performed due to the product being disposed of following removal. Info received to date indicates the pt had 3-4 previous miscarriages; this pregnancy was the first live birth. The pt came to the hospital the night before to have the balloon placed and begin the ripening of the cervix. The balloon was placed in the pt, and she was sent home. The next morning, the pt returned to have the balloon removed as well as a vaginal exam. The hospital was experiencing several pts in active labor and advised the pt to go to a family practice physician who also takes some obstetrical calls. The physician removed and disposed of the balloon around 9-9:30 am and indicated the pt was approx. 4-5 cm dilated with intact membranes. At 4:32 pm, the pt was admitted to the hospital's labor and delivery ward. Later, the pt administered pitocin and had an amniotomy performed to induce labor; amniotomy performed at 6:15 pm. Following the amniotomy, evidence presented of cord prolapse. Therefore, the physician quickly moved the pt to emergency cesarean section. The cesarean section was performed by an obstetrician. The baby was safely delivered, however the mother soon 'crashed'. The pt did not recover and expired on the table. The presumed diagnosis is amniotic fluid embolism, however that has not been confirmed and an autopsy was performed. Two cook group physicians (which include an obstetrician) have reviewed the file info and have indicated that the cervical ripening balloon was likely not the cause of the pt death primarily based upon the fact that the balloon was removed approx. 9-10 hours prior to the cesarean section. It was also noted that when the balloon was removed, the membranes were not ruptured. And the pt was judged to not be in active labor. Several hours prior to the cesarean section, the vascular system would not have been in a compromised state, particularly in the area of the cervix that would have allowed for intrusion of amniotic fluid or other debris, as the preliminary cause of death was noted as an amniotic fluid embolism. As an add'l note, there are several clinical references that indicate both cord prolapse and cesarean section being positively associated with amniotic fluid embolism. We are currently investigating this situation and will update the fda as add'l info becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2008-00023 |
| MDR Report Key | 1068216 |
| Report Source | 05,06,07 |
| Date Received | 2008-06-30 |
| Date of Report | 2008-06-17 |
| Date of Event | 2008-05-30 |
| Date Mfgr Received | 2008-06-10 |
| Device Manufacturer Date | 2007-04-01 |
| Date Added to Maude | 2008-07-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | TAMMY BACON |
| Manufacturer Street | 1100 WEST MORGAN ST. |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CERVICAL RIPENING BALLOON |
| Generic Name | CERVICAL DILATOR |
| Product Code | MCR |
| Date Received | 2008-06-30 |
| Model Number | NA |
| Catalog Number | J-CRB-184000 |
| Lot Number | U1636461 |
| ID Number | NA |
| Device Expiration Date | 2010-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1036101 |
| Manufacturer | COOK UROLOGICAL, INC. |
| Manufacturer Address | SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-06-30 |