It is reported that during an unblinded randomized clinical trial of methods for inducing labor, the patient had a cook cervical ripening balloon placed.After an unspecified time interval, the patient had a spontaneous vaginal delivery with a blood loss of 700ml following delivery.Approximately 2 hours later, the patient required surgical/manual removal of her placenta, and had an additional 1000ml of blood loss.The patient was given ergometrine 500mcg intramuscularly, syntometrine 2 ml intramuscularly, and syntocinon 40iu intravenously to treat post-partum hemorrhage with resolution.In addition, the patient was given the antibiotics cefuroxime 1.5 gm intravenously, and metronidazole 500mg intravenously prophylactically due to surgical intervention.The physician stated that there is no causal relationship between the cook cervical ripening balloon and the events reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.
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Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation the device was not returned for an evaluation and no photographs were provided.Without the device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of the instructions for use, quality control data, and trends.A review of the device history record could not be performed due to the user facility did not provide the lot number of the device.A review of complaint history on the device lot could not be performed because the lot number was not provided.The instructions for use (ifu) that accompanies this device provides the following warnings and precautions: warnings concomitant use of the cook cervical ripening balloon with exogenous prostaglandins may increase the risk of adverse events associated with prostaglandin administration, including, but not limited to: uterine hyperstimulation, impaired utero-placental circulation, tachsystole, uterine rupture, placental abruption, amniotic fluid embolism, pelvic pain, retained placenta, severe genital bleeding, shock, fetal bradycardia, fetal death, and maternal death.The stylet should only be used to transverse the tip of the catheter through the cervix and should be removed as soon as the uterine balloon is above the level of the internal uterine opening (internal os) prior to full insertion of the catheter.Aggressive insertion may result in injury to the baby.The product should not be left indwelling for longer than 12 hours.The safety and effectiveness of the cook cervical ripening balloon has not been established among women with an obstetrical history of low transverse caesarean section.The safety and effectiveness of extra-amniotic saline infusion with the cook cervical ripening balloon has not been established.Always inflate the balloon with a sterile saline.Never inflate with air, carbon dioxide or any other gas.Do not overinflate.Using excessive pressure to inflate the balloon on this device can cause the balloon to rupture.If spontaneous rupture of membrane occurs while the cook cervical ripening balloon is in place, there is a risk that the uterine balloon could become entangled in the umbilical cord, necessitating emergent cesarean delivery.Precautions if fetal membranes rupture spontaneously while this device is in place, it is recommended that both balloons be deflated and the device removed in preparation for spontaneous active labor contractions.A review of relevant manufacturing documents was conducted.It was concluded that the device in question was functionally inspected by quality control, and no notable gaps in production or processing controls were noted.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.Based on the additional information provided by the customer, the initial complaint cannot be confirmed.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.Monitoring will continue to be performed for similar complaints.The appropriate cook personnel have been notified of this event.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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