MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-12-20 for COOK CERVICAL RIPENING BALLOON J-CRB-184000 manufactured by Cook Urological, Inc..
[21946349]
(b)(4) - converting to c-section is not labeled in the ifu. (b)(4) - balloon rupture is not labeled in the ifu. One used complaint device was returned in a (b)(6) bag containing approx 70 ml to assist in this investigation. The vaginal balloon was partially inflated with 7 ml to a diameter of 2 cm. The uterine balloon was completely separated at both bonds and was not returned. Under magnification, both bonds of the uterine balloon were observed to be complete, with adequate glue. The remaining dimensions were within spec. Visual examination gave no indication of what caused the balloon to rupture and separate. This is the first occurrence of balloon separation. Typically when this balloon ruptures, it remains in one piece. The unusual aspect of this complaint is that the ruptured balloon completely separated. There is no evidence to indicate the root cause of the separation, although excessive pressure is likely the cause of the initial rupture. In addition, as noted in the user facility narrative, the uterine balloon was placed following the rupture of the membrane in the pt. The instructions for use for the product clearly contraindicates use in pts with ruptured membranes. It is unclear, however, whether or not off label use contributed to the rupture of the balloon. The balloon supplier 100% leak-tests the devices prior to shipping to cook. Cook incoming qc (iqc) also performs level 2 inspection of devices. We will continue to monitor for similar events. A risk assessment shows that the risk priority number remains acceptable with the inclusion of this complaint. No actions are necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
[22046843]
On (b)(6), the physician filled the double balloon catheter to the maximum capacity of 80cc in both balloons. The pt felt a pop and went to the rest room and the balloon fell into the toilet. The distal balloon was popped and the silicone portion that makes the balloon was missing. The physician informed the cook rep that the main concern was that the baby would aspirate the piece of silicone. At that point the physician told the rep that the pt was rupture and therefore, the immediate risk was greater. The physician informed the cook rep that the pt was insisting on a c-section due to the risks and the rep told her to do whatever was best for the mon and baby. Add'l info received (b)(6) 2012 - the first piece of info is that the product was placed in a pt that had ruptured membranes. This is a contraindication for placement. Cesarean section was performed due to a retained product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825146-2012-00031 |
| MDR Report Key | 2887388 |
| Report Source | 07 |
| Date Received | 2012-12-20 |
| Date of Report | 2012-11-23 |
| Date of Event | 2012-11-23 |
| Date Facility Aware | 2012-11-23 |
| Report Date | 2012-11-23 |
| Date Mfgr Received | 2012-11-26 |
| Device Manufacturer Date | 2012-09-25 |
| Date Added to Maude | 2012-12-28 |
| 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 | 2012-12-20 |
| Returned To Mfg | 2012-12-04 |
| Model Number | NA |
| Catalog Number | J-CRB-184000 |
| Lot Number | U2256317 |
| ID Number | NA |
| Device Expiration Date | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 2012-12-20 |