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 No Code Available (3191)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

Reporter name and address: postal code: (b)(6).Reporter occupation: head of midwifery & gynaecology.(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 after induction of labor using a cook cervical ripening balloon w/stylet (crb), an umbilical cord prolapse occurred.Provided details and sequence of events as follows: on (b)(6) 2019 at 18:05: crb was placed.It was difficult to insert (difficulty unspecified).Fetal position at time of insertion reported as " long cephalic left occiput posterior (lop) 4/5 palp.Vaginal exam (ve) -2 to spines", membranes intact.Confirmed by abdominal palpation.Cardiotocography (ctg) was performed post balloon placement (findings not specified).21:45: ctg (findings unspecified).On (b)(6) 2019 at 02:00: fetal heart rate heard (findings unspecified).07:30: crb removed after being indwelling around 13 hours, ctg continuous until delivery.It is reported that the crb did not malfunction in any way.08:00: ctg repeated (findings unspecified).10:10:* artificial rupture of membranes (arm) was performed, fetal station at the time of arm was reported to be "-2 from spines".10:25*: syntocinon started.13:30: fetal heart rate heard (findings unspecified).19:00: ctg repeated (findings unspecified).19:30: ctg continuous until delivery.Ctg was reported to be mostly normal until a prolonged deceleration in the fetal heart rate at 4cm dilation.22:20: vaginal exam for delayed first stage, maternal request.And syntocinon infusion for 12 hours.6cm dilation.23:06: patient was taken to the operating room (or) for category 1 lower segment cesarean section (lscs).Vaginal exam in the or 6cm, cord presentation felt, -2 station.23:47: baby was born in good condition.Times of arm and syntocinon initiation on document provided by the customer list 22:10, and 22:25 respectively.Based on the other details and timeline provided, it is assumed that those times are 10:10 and 10:25.Verification has been requested.No additional consequences to the patient have been reported.Additional details regarding the patient/event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

Additional information: b5.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information provided by the customer: it was clarified, the cook cervical ripening balloon w/stylet (crb) was difficult to place because the cervix was posterior and 1cm dilated.The senior midwife was able to successfully insert it.Clarification of date/time of artificial rupture of membranes (arm) (b)(6) 2019 at 22:10.Clarification of date/time of syntocin initiation (b)(6) 2019 at 22:25.

Manufacturer Narrative

H6: method code -communication/interviews (4111).Investigation evaluation: a customer reported a total of 10 cases in which a cord prolapses occurred after induction of labor using cook cervical ripening balloons (crb) across three different facilities within a hospital trust over the course of one year (01jan2019 - 31dec2019).In all reported cases, it was confirmed that there was no product malfunction, and these incidences of cord prolapse occurred after the crb had been removed.(the other nine cases were reported under mdr numbers:1820334-2020-00357, 1820334-2019-01262, 1820334-2020-1261, 1820334-2020-00416, 1820334-2020-00349, 1820334-2020-00347, 1820334-2020-00348, 1820334-2020-00294, and 1820334-2020-00413).This complaint details the sixth case.It was noted that the device was difficult to insert.The device was removed 13 hours later.The membrane was artificially ruptured over 2 hours later.12 hours later, the patient was taken to the operating room for a lower segment cesarean section and cord presentation was felt.40 minutes later, the baby was delivered in good condition.No malfunction of the complaint device was reported.Reviews of complaint history, device history record, trends, quality control data and the instructions for use(ifu) were conducted during the investigation.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use contraindicate, "presenting part above the pelvic inlet." in this case fetal station/position/lie at time of crb placement described as long lie, cephalic presentation, left occiput posterior (lop) 4/5 palpable on manual palpation.Fetal position on vaginal exam -2 to spines.The ifu specifically warns, "the product should not be left indwelling for longer than 12 hours." as reported in this case, the complaint device was left indwelling for 13 hours.The device had been out for over 16 hours prior to umbilical cord prolapse.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 all of the 10 cases reported by the 3 facilities within the nhs trust, arm was 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 (b)(4).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.We will continue our monitoring of similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

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
• MDR Report Key: 9708940
• MDR Text Key: 192456896
• Report Number: 1820334-2020-00350
• Device Sequence Number: 1
• Product Code: PFJ
• UDI-Device Identifier: 00827002198913
• UDI-Public: (01)00827002198913(17)220614(10)9810676
• 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,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2022
• Device Model Number: G19891
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: 9810676
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 52