MAUDE Adverse Event Report: COOK INC COOK CERVICAL RIPENING BALLOON W/STYLET; PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA

Model Number G19891

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death, Intrauterine Fetal (1855)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

Reporter name and address: postal code: (b)(6).Reporter occupation: head of midwifery & gynaecology.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported a cook cervical ripening balloon w/stylet (crb) was used for mechanical induction of labor for "post dates".The reported sequence of events are as follows: at 11:25, the crb was placed and the balloons were inflated with 80mls of normal saline.The amniotic membranes were intact at the time of crb placement with fetal lie described as long lie, cephalic presentation, right occiput anterior 2/5th's palpable on manual palpation.Fetal position on vaginal exam at the time of placement was -2 station.It was reported that the patient was monitored with ctg (cardiotocography) prior to crb insertion for an unspecified length of time and the tracing was normal.At 1215, 40 minutes after crb placement the patient experienced spontaneous rupture of membranes (srom).Fetal heart rate at srom was normal.At 12:25, 10 minutes after srom, the crb was removed.Fetal heart rate at balloon removal was normal.It is reported that the crb did not malfunction in any way, and "no harm came to the patient during the balloon insertion or removal." from 12:25-2300 the patient had "normal labor with fetal heart rate 132-144." at 2300, contractions were 3 in 10 minutes and vaginal exam was 4cm dilated, cervix central and effaced with presenting part at -2 station.Patient transferred to birthing pool.At 0130, the patient was contracting well, the fetal heart rate became tachycardic (rate unspecified).At 0157, the patient was transferred to labor ward.At 0159, fetal bradycardia (rate unspecified) was noted and immediately reviewed by the physician-cord prolapse was diagnosed.At 0203, emergency lower segment cesarean section (lscs) protocol initiated with fetal presenting part held off the umbilical cord by the midwife.No fetal heart tones were heard immediately prior to lscs.At 0216, lscs delivery with pediatricians present-resuscitation commenced but unsuccessful.No additional consequences to the patient (mother) were reported as a result of this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.H6: ec method code desc - 5: communication/interviews (4111).Investigation ¿ evaluation.(b)(6) hosp.Nhs trust informed cook on 24jan2020 of an incident involving at least one cook cervical balloon with stylet (j-crbs-184000) from production lot 9819046.As reported, the device was placed and the balloons were inflated with 80mls of normal saline.Fetal position on vaginal exam at the time of placement was -2 station.50 minutes after crb placement the patient experienced spontaneous rupture of membranes (srom).10 minutes after srom, the crb was removed.The patient continued to be in labor for 13 hours and 34 minutes before cord prolapse was diagnosed.17 minutes later an emergency lower segment cesarean section delivery was performed.No fetal heart tones were heard immediately prior to the cesarean procedure.Neonatal resuscitation was attempted but unsuccessful.The complainant confirmed that there was no device malfunction associated with this incident.A document-based investigation was performed including a review of complaint history, device history record, quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows one other complaint associated with the complaint device lot.Due to the individual nature of the manufacturing and inspection process for the devices in the lots, it is unlikely that these events are an indication of device issue within the entire lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: contraindications; "prolapsed umbilical cord." "presenting part above the pelvic inlet." "ruptured membranes." the complaint device was not returned to cook for investigation.Cook has not received a complaint for a similar product and a similar failure mode in which the complaint product was returned for physical examination.Clinical assessment: according to information provided by the customer, fetal position/station/lie were determined by manual palpation.There is no mention of ultrasound (us) being used to confirm these findings.The accuracy of manual palpation is largely dependent on the skill and experience of the practitioner performing the task.Us is a much more accurate method of assessing fetal position/station/lie and confirming presenting part prior to and during the labor induction process.Per the ifu: contraindications for cervical ripening using a crb include: presenting part above the pelvic inlet.In this case fetal station/position/lie at time of crb placement described as long lie, cephalic presentation, right occiput anterior (roa) 2/5th's palpable on manual palpation.Fetal position on vaginal exam at the time of placement was -2 station.Per the ifu: contraindications for cervical ripening using a crb include: ruptured membranes; the product should not be left indwelling for longer than 12 hours.As reported in this case, the crb was left indwelling for 50 minutes until srom.10 minutes after srom, crb was removed.Fetal station at the time of srom was not specifically provided.It was reported however approximately 10.5 hours after srom the fetal station was still at -2 station.This indicates that the fetal presenting part was not fully engaged within the pelvic inlet at the time of srom, and the ongoing labor course allowing space for the umbilical cord to prolapse.It should be noted that umbilical cord prolapse is a known risk factor inherent with vaginal deliveries.There are many factors that contribute to this risk including parity, amniotic fluid volume variances, prematurity, fetal station, umbilical cord length, etc.The occurrence rate of umbilical cord prolapse with vaginal deliveries worldwide is approximately 0.6% not considering of any methods for labor induction.Artificial rupture of membranes increases this risk.In 9 of 10 cases reported by the 3 facilities within the nhs trust, arm was attempted or performed after the crb was removed.The total birth rate between 2 of the 3 facilities for 2019 was 4798 (number of births in 2019 for the third facility not provided).Even without adding in the births for the third facility to the total for the year, 10 cases of cord prolapse out of 4798 births falls far below the global occurrence rate of 0.6%.The risk of neonatal death related to umbilical cord prolapse is approximately 10%.In this case, the fetus showed signs of intrauterine distress approximately 46 minutes before birth (and 33 minutes prior to initiation of the emergency lscs).It was noted, that there was an absence of fetal heart rate detected just prior to commencement of the lscs delivery.This prolonged distress, coupled with the absence of fetal heart rate immediately prior to the delivery made the likelihood of successful resuscitation very poor.Based on the provided information the most probable contributing factors include failure to follow the ifu, fetal station/head engagement at the time of srom and throughout labor, prolonged intrauterine fetal distress, and user assessment technique.Based on the available information, it was concluded that the user's failure to follow instructions likely contributed to the reported incident.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new patient or event information since the last report was submitted.

• Brand Name: COOK CERVICAL RIPENING BALLOON W/STYLET
• Type of Device: PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9673045
• MDR Text Key: 190971079
• Report Number: 1820334-2020-00294
• Device Sequence Number: 1
• Product Code: PFJ
• UDI-Device Identifier: 00827002198913
• UDI-Public: (01)00827002198913(17)220618(10)9819046
• Combination Product (y/n): N
• PMA/PMN Number: K131206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2022
• Device Model Number: G19891
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: 9819046
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 64