It was reported, a cook cervical ripening balloon w/stylet was used to dilate the cervix prior to induction of labor.Fetal presentation was cephalic prior to insertion of the device and after insertion of the device the fetus turned up into a podalic presentation.An "upheaval" of the fetus was performed to turn down the head of the fetus without success.A cesarean section(c-section) was performed.No additional patient consequences were 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, unavailable, or unchanged.Event summary it was reported, a cook cervical ripening balloon w/stylet was used to dilate the cervix prior to induction of labor.Fetal presentation was cephalic prior to insertion of the device and after insertion of the device the fetus turned up into a podalic presentation.An "upheaval" of the fetus was performed to turn down the head of the fetus without success.A cesarean section(c-section) was performed.No additional patient consequences were reported.Investigation - evaluation.Reviews of the instructions for use and quality control procedures of the device were conducted during the investigation.No device was returned for investigation, and no lot number was provided.Accordingly, no physical examination or device history record review could be conducted.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use, which warn, ¿if spontaneous rupture of membranes 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.¿ the ifu states that breech presentation is a contraindication for device use and that the need for caesarean delivery is a potential adverse event.Based on the available information, cook has concluded that the cause of the event cannot be traced to the device, but to patient condition.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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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