MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-02-16 for COOK CERVICAL RIPENING BALLOON W/STYLET J-CRBS-184000 manufactured by Cook Inc.
[100293516]
(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[100293517]
It was reported on 18jan2018, "sadly, we have had a term intra-uterine fetal demise (iufd) related to potential severe sepsis after a cook's balloon in a mother with gestational diabetes last week. " sequence of event details provided on 22jan2018: on (b)(6) 2018 at 2240 hrs - j-crbs-184000 inserted. On (b)(6) 2018 at 2245 hrs - j-crbs-184000 removed (asymptomatic of septicemia). On (b)(6) 2018 at 0600 hrs - patient waiting for arm (ctg and fhr heard at 155bpm). On (b)(6) 2018 at 1815 hrs - ctg performed and no fhr heard (asymptomatic of septicemia at this stage). On (b)(6) 2018 at 1815 hrs - iud confirmed. On (b)(6) 2018 at 0900 hrs - baby still not delivered but patient has pyrexia. Temperature of 38. 1 degrees. At 3-4cms dilated. On (b)(6) 2018 at 1902 - demised baby delivered via cesarean section (copious offensive puss draining as doctors entered uterine cavity to retrieve the baby). Further information provided was the arm was performed 19 hours after the cook cervical ripening balloon was removed. The patient was treated with antibiotics following the iud diagnoses. The patient discharged home on sunday (b)(6). It was stated that it is not known if the device contributed to the sepsis. The ifu states the cook cervical ripening balloon is not intended to be in place for longer than 12 hours. Time the placement of the device to 12 hours prior to the planned induction. It was stated that the device will not be returned.
Patient Sequence No: 1, Text Type: D, B5
[106878465]
Investigation? Evaluation. The coda balloon device was not returned for an analysis and the lot number of the device was not provided. Without the complaint device, a physical investigation was not able to be completed. A document based investigation has been performed which includes a review of the instructions for use, quality control data, and device specifications. The j-crbs-184000 is used for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction. The timeline of events shows the j-crbs-184000 was placed for >24 hours ((b)(6) 2018 at 22:40 until (b)(6) 2018 at 22:45). The instructions for use provides the following instructions: the product should not be left indwelling for longer than 12 hours. Always inflate the balloon with a sterile saline. Time the placement of the device 12 hours prior to the planned induction. Sterile if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Upon removal from the package, inspect the product to ensure no damage has occurred. As documented in the instructions for use (ifu),? The product should not be left indwelling for a period greater than 12 hours.? No information was provided as to what substance was used to inflate the device. As instructed in the ifu,? Always inflate the balloon with a sterile saline.? There is no information regarding patient preparation prior to placement of the device. There is no information regarding inflation of the balloon or device preparation. According to the ifu,? Upon removal from the package, inspect the product to ensure no damage has occurred.? There is no information regarding product shipping or storage. As per the ifu,? Sterile if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile.? No rationale was provided for waiting 19 hours after removal of the j-crbs-184000 to perform artificial rupture of membranes (arm). As stated in the ifu,? Time the placement of the device 12 hours prior to the planned induction.? Additional patient and event information has been requested from the user facility however they have declined to provide further information. The user facility contact response,? We would be breaching the patient? S confidentiality.? It should be noted that the patient had gestational diabetes. Diabetic patients are at higher risk for infection. There is no patient history for review including history of previous births (if any) and outcome of those births. There are no cultures for review. There is no evidence at this time that suggests any causal relationship between the j-crbs-184000 and the fetal death. The lot number of the coda balloon device was not available; therefore, a review of the device history records could not be completed. A review of complaint history for the associated device lot also could not be performed as the lot information was not available. Based on the information available, the most probable causes of this event are likely device handling and storage, device use and preparation, disease progression or pre-existing condition related. The appropriate manufacturer personnel have been notified of this event. Per the quality engineering risk assessment, no further action is warranted. Monitoring will continue to be performed for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2018-00213 |
| MDR Report Key | 7277528 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-16 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-01-15 |
| Date Mfgr Received | 2018-03-30 |
| Date Added to Maude | 2018-02-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CERVICAL RIPENING BALLOON W/STYLET |
| Generic Name | PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA |
| Product Code | PFJ |
| Date Received | 2018-02-16 |
| Catalog Number | J-CRBS-184000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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. Death | 2018-02-16 |