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

Catalog Number J-CRBS-184000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

Date of event: (b)(6) 2020.Reporter name and address: postal code: (b)(6).(b)(4).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 during induction of labor using a cook cervical ripening balloon w/stylet (crb) an umbilical cord prolapse occurred.Two cases were opened related to this event, one to report the effects to the mother (patient identifier (b)(6)), and one to report the effects to the infant (this report) sequence of events as follows: 14:20 (30 minutes prior to crb placement): cardiotocography (ctg) "normal".14:50: cervical exam 1cm dilated by 2cm long-crb was inserted with ease, 80mls saline in each balloon.Head was 3/5th palpable on abdominal palpation.(ultrasound was not used prior to insertion of balloon).**fetal heart rate (fhr) was checked once after crb insertion-time and findings not provided** 16:00: the patient reported spontaneous rupture of membranes (srom) and small flecks of meconium on the pad.When auscultated, the fetal heart rate was 50 beats per minute (bpm).The crb was taken out and on vaginal exam (ve) there was a cord prolapse.16:13: patient was in the operating room for an emergency cesarean delivery.16:29: baby was born in poor condition.The baby was cooled (hypothermia treatment), however the baby was very unwell and had multiple seizures.After 5 days of life, treatment was withdrawn and the baby died.The baby had no congenital anomalies.It was confirmed that the crb did not malfunction in any way.

Manufacturer Narrative

Event description: cook was informed of an incident involving a cook cervical balloon with stylet from an unknown production lot.As reported, the patient was a para 1 previous forceps delivery who was being induced for postdates.The pregnancy was uneventful and low risk.The head was 3/5th palpable on abdominal palpation.The patient was 1cm dilated by 2cm long when the cervical balloon device was inserted and each balloon was inflated with 80ml of saline.Ultrasound was not used prior to insertion of balloon.1 hour and 10 minutes later, spontaneous membrane rupture was reported, small flecks of meconium were on the pad, and the fetal heart rate was 50 beats per minute (bpm).The balloon device was removed, and on the vaginal exam (ve) there was a cord prolapsed.13 minutes later, the patient was in theater for an emergency cesarean.16 minutes later the baby was born in poor condition.Following the delivery, the mother physically recovered.The baby was cooled (hypothermia treatment), however the baby was very unwell and experienced multiple seizures.At (b)(6) of life treatment was withdrawn and the baby passed away.The baby had no congenital anomalies.No malfunction of the complaint device was reported.Investigation - evaluation reviews of instructions for use (ifu), and quality control data were conducted during the investigation.The complaint device was not returned for investigation.Review of the customer testimony and relevant manufacturing documents indicates that the device was manufactured within specifications and does not suggest items in the lot or similar devices in the field or in house are nonconforming.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of complaint history records could not be completed due to lack of lot information from the user facility.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: contraindications "presenting part above the pelvic inlet" warnings "if spontaneous rupture of membranes occurs while the cook cervical ripening balloon is in place, there is a risk that the uterine balloon could become entangled in the umbilical cord, necessitating emergent cesarean delivery." instructions for use "patient preparation" "1.Perform an abdominal ultrasound to confirm singleton, vertex presentation and to rule out partial or complete placenta previa and/or placenta percreta." 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.From the information available, clinical assessment has determined the most probable contributing factors include; failure to follow the ifu, fetal station/head engagement, and known inherent risks for vaginal delivery (cord prolapse).Based on the available information, it was concluded that the cause of this incident cannot be traced to the complaint device.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue to monitor for similar complaints.

Event Description

There is no new patient or event information to report.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 10333021
• MDR Text Key: 200627223
• Report Number: 1820334-2020-01369
• Device Sequence Number: 1
• Product Code: PFJ
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K131206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death