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 20:10 crb was placed.Fetal position at time of insertion reported as " long cephalic left occiput anterior (loa) 3/5 palp.", membranes intact.Confirmed by abdominal palpation.Cardiotocography (ctg) was performed post balloon placement (findings not specified).On (b)(6) 2019 at 1430: ctg repeated (findings unspecified).14:27: the crb was removed.It is reported that the crb did not malfunction in any way.14:37: moved to labor ward and continuous ctg monitoring until delivery (findings not specified).14:42: artificial rupture of membranes (arm) was performed, fetal position/station at time of arm described as " -2 to spines, palpated cephalic, cord felt." 14:44 : the patient was taken to the operating room (or) for category 1 lower segment cesarean section (lscs), spinal anesthesia was administered.15:14: baby born breech 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.
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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 (b)(6) 2019).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:1820334-2019-01261, 1820334-2019-01262, 1820334-2020-00347, 1820334-2020-00416, 1820334-2020-00349, 1820334-2020-00350, 1820334-2020-00357, 1820334-2020-00294, and 1820334-2020-00413).This complaint details the fourth case.The complaint device was placed and remained indwelling for 18 hours and 17 minutes.15 minutes afterwards, artificial rupture of membranes (arm) was performed, and the cord was felt.The patient was then moved to the operating room for a lower segment cesarean section.30 minutes later the baby was delivered in good condition.No malfunction of the complaint device was reported.Reviews of complaint history, device history record, 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.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 the time of crb placement was described as long lie, cephalic presentation, left occiput anterior (loa) 3/5th's palpable on manual palpation.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.
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