MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-05-08 for COOK CERVICAL RIPENING BALLOON J-CRB-184000 manufactured by Cook Urological, Inc..
[2764735]
Physician has experienced two "isolated" cervical laceration occurrences in pts using the crb and one cervical laceration extending into a lower uterine rupture which resulted in a hysterectomy. Discussion on (b)(6), physician stated the incidences that had occurred with the device involved "a team of residents" that happen to be working in the department at the time. He indicated he "was not fully convinced that the problems which had occurred were an issue with the balloon. " one with a hysterectomy other two pts lacerations were repaired "unremarkable. "
Patient Sequence No: 1, Text Type: D, B5
[9925836]
A proper evaluation cannot be performed due to the product(s) being disposed of following use. However, several cook women's health representatives visited the facility to gain additional information concerning the incidents. The additional obtained indicates on (b)(6) 2009, a (b)(6) pt was admitted for a scheduled induction of labor. The pt was reported to have had three prior births with no complications, and this pregnancy did not have any "high risk" symptoms other than being past 40 weeks. The induction began, noting a normal fetal heart rate. The cervical ripening balloon was placed noting 60 cc of fluid in each balloon. One hour after balloon placement, pitocin was started per hospital protocol of 1-2 units/liter per hour up dosage every 30 minutes. From the time the pitocin was started, the pt was given up to 18 u/l of pitocin; over approximately a 12 hour period. When the balloon was removed, nearly 14 hours after balloon placement, the pt was noted to be dilated to 6 cm and the fetal heart rate was decelerating, hence the need to remove the balloon. There was no mention of cervical laceration when the balloon was removed. The baby was delivered breech via cesarean section. The surgical notes indicate the uterus was large and blue with a uterine rupture observed on the right lateral aspect of the uterus. Good uterine muscle tone was exhibited after pitocin was administered. Attempts were made to close the uterine tear and laceration, but brisk bleeding was still noticed. Hysterectomy was performed and the left ureter was ligated during the hysterectomy resulting in a urology call. The cervical laceration was not a total laceration. It was only noticed on the uterine side of the cervix. The customer also reported two additional pts that were noted to have a cervical lacerations; both inductions were performed by residents. The laceration were observed at delivery and not when the cervical ripening balloons were removed and both lacerations were repaired "unremarkable. " the chief resident indicated both pts were at 2 cm when the balloon were placed and progressed very quickly. At this time, we are unable to obtain any additional information concerning the two pts that received lacerations. It should be noted on all three of these cases, a cervical laceration was noted, but not upon removal of the cervical ripening balloon. The lacerations were not observed until after delivery and none of the three were complete cervical laceration/tears and were only noted on the uterine half of the cervix. As stated in the information for use booklet, "product should not be left indwelling for a period greater than 12 hours. " the chief of regional perinatology as well as the labor and delivery nurse involved indicated the cervical ripening balloon was not likely the cause of these incidents. Due to the products not being returned for evaluation and limited information concerning the other two incidents, we are unable to determine or recreate the difficulty experienced. Should additional information become available, it will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2009-00015 |
| MDR Report Key | 2619059 |
| Report Source | 05,06 |
| Date Received | 2009-05-08 |
| Date Mfgr Received | 2009-04-09 |
| Date Added to Maude | 2012-06-19 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS KILANDER |
| Manufacturer Street | 1100 WEST MORGAN |
| 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 | 2009-05-08 |
| Catalog Number | J-CRB-184000 |
| Lot Number | UNKNOWN |
| 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; 2. Deathisabilit | 2009-05-08 |