MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2018-07-12 for COOK? CERVICAL RIPENING BALLOON J-CRB-184000 manufactured by Cook Inc.
[113869719]
(b)(6). 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
[113869720]
It was reported a cervical ripening balloon, which we use for a mechanical balloon induction, was inserted in a pregnant patient and 4 hours after insertion (2 hours after it was removed) there was a cord prolapse and the fetus died. "the manufacturer? S instructions are unhelpful as they only contraindicate it if the head is? Above the pelvic inlet? Nor does the manufacturer list cord prolapse as a risk. " per the instructions for use (ifu): intended use: the cervical balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction. Contraindications: (... ) transverse fetal orientation, prolapsed umbilical cord, (... ) breech presentation, (... ) presentation above the pelvic inlet, (.... ) warnings: (... ) if spontaneous rupture of membranes occurs while the cervical balloon is in place, there is a risk that the uterine balloon could become entangled in the umbilical cord, necessitating emergent cesarean delivery. Requests were made for additional information on 19jun2018, 21jun2018, 26jun2018, and an onsite visit 05jul2018 including the questions listed below. The customer has not provided any further information at the time of this report. 1. What is the attending physician? S opinion of the cause of fetal cord prolapse? 2. Please provide maternal patient information: a. Age/weight of the mother: b. Relevant maternal health history including pre-existing conditions: c. Did the mother experience any pre-natal issues, for example: pre-eclampsia, placenta previa, gestational diabetes, clotting disorders, etc: i. If so, please provide at what point in the pregnancy these were diagnosed and course of treatment given: 3. Please provide the gestational age, weight, and length of fetus: 4. Prior to labor, was an ultrasound conducted? A. If yes, can ultrasound images be provided? 5. Please describe the procedure in detail: a. Please provide the time the device was inserted. B. Please provide the time the device was removed and the reason for removal. C. When the device was inserted were the patient? S membranes intact? D. Did the patient? S membranes rupture? If, so what time in the procedure did this occur? E. Please provide all additional devices and/or medications given during this procedure: f. Was the fetus? Heart-rate monitored during the induction and labor process? I. If yes- did the heart-rate of the fetus remain steady or fluctuate during contractions? Were there any changes in fetal heart rate during the time that the cervical ripening balloon was in place? Ii. If yes- what time did fetal heart rate decelerate? Iii. Was the cervical balloon in place at the time of the deceleration? G. At the time of the cord prolapse, what was the birth station of presentation and what was the delivery presentation of the baby? H. Please describe the placenta that was delivered after the baby. 6. Please provide any operative reports (op), records, videos, scans, notes related to this procedure. 7. Was an autopsy conducted? A. If yes, can a copy of the report be provided?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01841 |
| MDR Report Key | 7683564 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2018-07-12 |
| Date of Report | 2018-08-20 |
| Date of Event | 2018-01-06 |
| Date Mfgr Received | 2018-08-15 |
| Device Manufacturer Date | 2015-06-17 |
| Date Added to Maude | 2018-07-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK? CERVICAL RIPENING BALLOON |
| Generic Name | PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA |
| Product Code | PFJ |
| Date Received | 2018-07-12 |
| Model Number | NA |
| Catalog Number | J-CRB-184000 |
| Lot Number | 5966823 |
| Device Expiration Date | 2018-06-17 |
| 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 INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-12 |