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 10/11/2019

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 40 weeks for "a big baby" using a cook cervical ripening balloon w/stylet (crb), an umbilical cord prolapse occurred.Provided details and sequence of events as follows: (b)(6) 2019 at 23:15-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 - 2 to spines.Membranes intact.Cardiotocography (ctg) was performed post balloon placement for 35 minutes (findings not specified).(b)(6) 2019 at 03:15: ctg repeated (findings unspecified).08:15-ctg repeated (findings unspecified).10:15* crb fell out after being indwelling for 23 hours.It was conformed that the crb did not malfunction in any way.12:15-ctg repeated (findings unspecified) with continuous monitoring for 2 hours 12:25-unsuccessful attempt to artificially rupture the membranes (fetal station at this time unknown).Hand felt.Attending physician review and ultrasound completed.Cord seen and vaginal exam resulting in spontaneous rupture of membranes (srom) resulted in cord prolapse.Cervical dilatation at the time 3cm.The patient was taken to the operating room for category 1 lower segment cesarean section (lscs).13:28-the baby was delivered with breech presentation.Apgar scores were: 1 minute: 4, 5 minute: 9, and 10 minute: 10.This time provided by the customer does not line up with the remaining time line provided.Verification has be 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

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 1820334-2020-00350).This complaint details the eighth case.After 11 hours indwelling, the device fell out.1 hour and 50 minutes later, artificial rupture of membranes was attempted and then again 20 minutes later.25 minutes later, spontaneous rupture of membranes occurred 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 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.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.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, right occiput anterior (roa) 3/5 palpable on manual palpation.Fetal position on vaginal exam -2 to spines.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

Additional information provided by the customer 24feb2020: 10oct2019 at 23:15-the cook cervical ripening balloon (crb) was placed 23:18 cardiotocography (ctg) was normal.Patient went home.On (b)(6) 2019 at 10:15.The balloon fell out.12:05-the patient returned to the unit and ctg was completed (normal findings), and first attempt of artificial rupture of membranes (arm).Fetal station -2.12:25-second (abandoned) attempt of arm performed.Ultrasound at that time by attending physician in room at 12:45 presenting part could not be visualized.The mother was mobilized.12:58-spontaneous rupture of membranes occurred.Ultrasound repeated at this time, cord was visualized to be the presenting part, patient was taken to the operating room.

• 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: 9738785
• MDR Text Key: 192676315
• Report Number: 1820334-2020-00413
• Device Sequence Number: 1
• Product Code: PFJ
• UDI-Device Identifier: 00827002198913
• UDI-Public: (01)00827002198913(17)220614(10)9810716
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• 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: 9810716
• 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): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 54