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

Catalog Number J-CRBS-184000

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

Patient Problem No Code Available (3191)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

Reporter name and address: postal code: (b)(6).Reporter occupation: head of midwifery & gynecology.(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 at term +1 for decreased fetal movement 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 23:10-crb was placed.Fetal position at time of insertion reported as " long cephalic right occiput anterior (roa) 3/5 palp", membranes intact.Confirmed by abdominal palpation.Vaginal exam - 3 to spines.Membranes intact.Cardiotocography (ctg) was performed post balloon placement (findings not specified).On (b)(6) 2019 08:00 ctg repeated (findings unspecified).14:00-ctg repeated (findings unspecified).19:40-ctg repeated (findings unspecified).20:10-crb removed after being indwelling for 21 hours.It was confirmed that the crb did not malfunction in any way.21:00-vaginal exam, presenting part at -3 station, failed attempt of artificial rupture of membranes (arm).Attending physician review-cord presentation.Patient was taken to the operating room (or) for category 2 lower segment cesarean section (lscs).21:40-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.

Event Description

No new patient or event information has been provided since the last report.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.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.This complaint details the tenth case (the other nine cases were reported under mdr numbers:1820334-2019-01261, 1820334-2019-01262, 1820334-2020-00347, 1820334-2020-00348, 1820334-2020-00349, 1820334-2020-00350, 1820334-2020-00357, 1820334-2020-00294, and 1820334-2020-00413).In this case, the complaint device was used to induce a patient prior to delivery.The device was left indwelling for 21 hours.50 minutes after removal of the complaint device, artificial rupture of membranes was attempted, and a prolapsed cord was felt.The patient was then transferred to an operating room for a lower segment cesarean section where the baby was delivered.The baby is currently alive and well.No malfunction of the complaint device was reported.Reviews of quality control data and the instructions for use(ifu) were conducted during the investigation.A review of the device history record (dhr) could not be completed due to lack of lot information from the user facility.A review of complaint history could not be completed due to lack of lot information from the user facility.The instructions for use for the device includes the following contraindication: "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) 3/5 palpable on manual palpation.Fetal position on vaginal exam -3 to spines.The ifu specifically warns, "the product should not be left indwelling for longer than 12 hours." as reported in this case, the crb was left indwelling for 21 hours.No complaint device was returned for investigation, and no lot number was provided.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(arm) increases this risk.In all of the 10 cases reported by the 3 facilities within this 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 recommended at this time.The failure mode will continue to be trended.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.

• 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: 9740202
• MDR Text Key: 192671151
• Report Number: 1820334-2020-00416
• Device Sequence Number: 1
• Product Code: PFJ
• 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: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 02/28/2020
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 75