MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-03-28 for COOK CERVICAL RIPENING BALLOON WITH STYLER C-CRBS-184000 manufactured by Cook Urological Inc.
[4306515]
The physician working with a 2 year resident during a procedure in (b)(6) 2013 for cholestasis of pregnancy. The cervix was 2cm dilated. The physician passed the balloon with stylet in place through the internal os, filled the internal balloon to 30cc and then applied traction to make sure it was secure. The balloon was noted to be in the cervix and then heavy vaginal bleeding was noted. The balloon was again checked and noted to be in the cervix when a second large gush of bleeding occurred. The balloon was deflated and removed. The stylet and tubing were noted to be intact. The pt continued to hemorrhage from what appeared to be two abrasions in the cervix at 3 o'clock and 9 o'clock. No large lacerations were noted. Ring forceps were placed on these two areas with hemostatics noted. After approximately 10 minutes of pressure with ring forceps, the areas were hemostatic. The pt's labor course was otherwise uncomplicated and progressed to have a vaginal delivery without any cervical abnormalities noted after delivery. This was her third vaginal delivery. The baby had no abnormal fetal heart rate tracings throughout the hemorrhage or rest of her labor course.
Patient Sequence No: 1, Text Type: D, B5
[11811413]
Event evaluation: still under investigation.
Patient Sequence No: 1, Text Type: N, H10
[55024144]
The pt did not require any add'l procedures due to this occurrence. According to the initial reporter, the pt did not experience any adverse effects due to this occurrence. Investigation eval: during investigation, a review of complaint history, drawing, instructions for use (ifu) and quality control (qc) was conducted. The product was not returned for investigation. Incoming quality control personnel inspects this device per specification, ensuring the product is free of excess debris and discoloration and that the tip is round, smooth and free of flash. An instructions for use (ifu) is provided that warns "the stylet should only be used to traverse the tip of the catheter through the cervix and should be removed as soon as the uterine balloon is above the level of the internal uterine opening (internal os) prior to full insertion of the catheter. Aggressive insertion may result in injury to the baby. " it also lists potential adverse events, including "cervical laceration" and "bleeding. " the ifu also provides steps on a method to insert the catheter with the provided stylet. It should be noted that abrasions were present at 3 and 9 o'clock positions on the cervix. A procedural video found on the cookmedical. Com website shows the j-crb-184000 being inserted with ring forceps, held at the 3 and 9 o'clock position. It is reasonable to assume that while the device was being inserted, an instrument was holding the device and scaped the cervix at the 3 and 9 o'clock positions, causing the abrasions. Without further info or a confirmation on the use of a device during insertion, a root cause can not be determined with certainty. The appropriate internal personnel have been notified and we will continue to monitor for similar complaints. Per the quality engineering risk assessment (qera) additional risk reduction activities are not needed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2014-00146 |
| MDR Report Key | 3736003 |
| Report Source | 07 |
| Date Received | 2014-03-28 |
| Date of Report | 2014-03-05 |
| Date of Event | 2013-08-01 |
| Date Facility Aware | 2013-08-01 |
| Report Date | 2014-03-05 |
| Date Mfgr Received | 2014-03-11 |
| Date Added to Maude | 2014-04-10 |
| 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 | RITA HARDEN, DIR |
| 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 WITH STYLER |
| Generic Name | HDY DILATER, CERVICAL |
| Product Code | HDY |
| Date Received | 2014-03-28 |
| Model Number | NA |
| Catalog Number | C-CRBS-184000 |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 2014-03-28 |