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 04/02/2019

Event Type  Injury  

Manufacturer Narrative

Reporter name and address: postal code: (b)(6).Reporter occupation: midwife.(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 11:50: crb was placed.Fetal position at time of insertion reported as " long cephalic left occiput anterior (loa) 2/5 palp", membranes intact.Confirmed by abdominal palpation.Cardiotocography (ctg) was performed post balloon placement (findings not specified).On (b)(6) 2019 at 02:30: ctg repeated (findings unspecified) at an unspecified time, the patient was moved to the labor ward and ctg was continuous until delivery.04:00: the crb was removed after being indwelling for 17 hours.It is reported that the crb did not malfunction in any way.04:08: artificial rupture of membranes (arm) was performed, and the cord was felt.Fetal position/station at the time of arm are unknown.Ctg was in progress and normal (confirmed by attending physician).04:40: the patient was taken to the operating room (or) for category 2 lower segment cesarean section (lscs), spinal anesthesia was administered.05:08: baby born in good condition.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

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, 1820334-2020-00350, 1820334-2020-00348, 1820334-2020-00294, and 1820334-2020-00413).This complaint details the third case.Fetal station at the time of device placement was not provided.The device was removed after 17 hours indwelling.Artificial rupture of membranes (arm) was performed, and the cord was felt.Fetal station at the time of arm was not provided.40 minutes later, a lower segment cesarean section was performed, and the baby was successfully delivered.The baby is currently alive and well.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 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 specifically warn, "the product should not be left indwelling for longer than 12 hours." as reported by the complainant, these instructions were not followed.Additionally, the ifu contraindicates, "presenting part above the pelvic inlet." in this case fetal station/position/lie at time of crb placement was not provided.No complaint device was returned for investigation.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.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 0.6%.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: 9707827
• MDR Text Key: 190975497
• Report Number: 1820334-2020-00347
• Device Sequence Number: 1
• Product Code: PFJ
• UDI-Device Identifier: 00827002198913
• UDI-Public: (01)00827002198913(17)211011(10)9227900
• 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: 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: 10/11/2021
• Device Model Number: G19891
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: 9227900
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 91