MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,study report with the FDA on 2015-04-17 for COOK? CERVICAL RIPENING BALLOON N/A J-CRB-184000 manufactured by Cook Inc.
[5649423]
A study site reported that a (b)(6) year old female pt underwent labor induction with a cervical ripening balloon (crb) and pitocin on (b)(6) 2015. The baseline clinical assessment revealed (b)(6) effacement, 2 cm dilation and -3 station. The cervix was posterior and soft. The crb was inserted on (b)(6) 2015 at 09:56. Insertion of the crb was considered very easy. The crb was removed at 12:49 and the cervix was dilated to 5 cm at that time. The pt received epidural anesthesia on (b)(6) 2015 beginning at 11:50. At 14:30 a vaginal exam revealed that the pt was 9 cm dilated and the cord was prolapsed. The pt was taken for c-section. The baby had low apgars at delivery and was admitted into nicu.
Patient Sequence No: 1, Text Type: D, B5
[13156867]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[32758170]
(b)(4). Event evaluation: a review of complaint history, instructions for use (ifu), and quality control was conducted during the investigation. The device was not returned to assist in the investigation. The ifu states appropriate uses, contraindications, warnings and precautions, potential adverse events including failed dilation or need for caesarean delivery, and proper usage instructions. There is no evidence to suggest that the device was not manufactured per specifications. It is unknown why the cord prolapse occurred, but the study facility marked that the device was unlikely related to the event. The device was removed approximately 1 hour and 40 minutes before discovering the cord prolapse. It was stated that the need to a c-section, was not due to the balloon. The complaint was confirmed based on customer testimony. The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[32758171]
A study site reported that a (b)(6) female patient underwent labor induction with a cervical ripening balloon (crb) and pitocin on (b)(6) 2015. The baseline clinical assessment revealed 70% effacement, 2 cm dilation and -3 station. The cervix was posterior and soft. The crb was inserted on (b)(6) 2015 at 09:56. Insertion of the crb was considered very easy. The crb was removed at 12:49 and the cervix was dilated to 5 cm at that time. The patient received epidural anesthesia on (b)(6) 2015 beginning at 11:50. At 14:30 a vaginal exam revealed that the patient was 9 cm dilated and the cord was prolapsed. The patient was taken for c-section. The baby had low apgars at delivery and was admitted into nicu. On 27-apr-2015 the site submitted an event form and indicated that this event was unlikely related to either the study device or study procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2015-00263 |
| MDR Report Key | 4713516 |
| Report Source | 02,STUDY |
| Date Received | 2015-04-17 |
| Date of Report | 2015-03-19 |
| Date of Event | 2015-03-15 |
| Date Facility Aware | 2015-03-15 |
| Report Date | 2015-03-19 |
| Date Mfgr Received | 2015-03-23 |
| Device Manufacturer Date | 2015-03-23 |
| Date Added to Maude | 2015-04-22 |
| 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 | 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 | 2015-04-17 |
| Model Number | N/A |
| Catalog Number | J-CRB-184000 |
| Lot Number | UNK |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| 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. Other | 2015-04-17 |