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

Model Number N/A

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

Patient Problem No Code Available (3191)

Event Date 08/23/2017

Event Type  Injury  

Manufacturer Narrative

Common device name: catheter, balloon, dilation of cervical canal.(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 was reported that a doctor had heard that two or three babies had changed position in the uterus after a j-crbs-184000 had been used.The doctor didn´t have much more information than this.As reported after follow up, the hospital has had two cases where the baby´s head changed position after using the j-crbs.The first case reported on this mfr.Report # 1820334-2018-02776 and second case is reported on mfr.Report # 1820334-2018-02777.The first case on (b)(6) 2017, "was a multiparous woman where the baby´s position was unstable (but the head was below the pelvic inlet) and the baby changed to transverse position after inserting j-crbs.They were not able to change it back to the right position and they had to perform a c-section." additional patient and event information has been requested but has not been received at the time of this report.The instructions for use that accompanies the cook cervical ripening balloon with adjustable stylet contains the following contraindications, warnings, and potential adverse events: contraindications: patient receiving or planning to undergo exogenous prostaglandin administration, placenta previa, vasa previa, or placenta percreta, transverse fetal orientation, prolapsed umbilical cord, prior hysterotomy, classic uterine incision, myomectomy or any full-thickness uterine incision, pelvic structural abnormality, active genital herpes infection, invasive cervical cancer, abnormal fetal heart-rate patterns, breech presentation, maternal heart disease, multiple gestational pregnancy, polyhydramnios, presenting part above the pelvic inlet, severe maternal hypertension, any contraindication to labor induction, ruptured membranes.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, tachysystole, 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 traverse 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 cesarean 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 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 caesarean delivery.Potential adverse events: risks associated with use of the cook cervical ripening balloon and labor induction may include, but are not limited to: placental abruption, uterine rupture, spontaneous rupture of membranes, spontaneous onset of labor, device expulsion, device entrapment and/or fragmentation, maternal discomfort during and after insertion, failed dilation or need for caesarean delivery, cervical laceration, bleeding, risk of pre-term labor and birth in subsequent pregnancy.

Manufacturer Narrative

Investigation evaluation: the complaint device was not returned for an evaluation and no photograph or imaging was provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, quality control data, and specifications.The device history record was reviewed noted there are no conformances that may have caused or contributed to this incident.A review of complaint history records revealed this to be the only complaint associated with the complaint device lot number 7783756.The baby¿s position was ¿unstable¿.It was not confirmed that the baby¿s head was engaged.There is no information regarding the mothers¿ activity or movements that may have also contributed to the baby¿s movement.After placement of the j-crbs-184000, the mother is able to remain active and is encouraged to move about.There is no information surrounding whether the mother may have had polyhydramnios.There are many reasons the baby may have moved after placement of the j-crbs-184000 including activities of the mother.This occurrence does not allege any device malfunction leading to the event.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The cause of this reported event could not be established.Per the quality engineering risk assessment, no additional risk mitigating activity is required at this time.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for 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

There has been no additional information received since the last report was submitted.

Event Description

Additional details were provided on (b)(6) 2019.The fetal station at time of device insertion was determined by outer palpation; fixated in pelvic inlet and inner palpation; above pelvic inlet.The cook cervical ripening balloon w/stylet was placed before amniotomy with bishop score 5.There were no difficulties placing the device.The balloons were inflated to 80 + 80 ml with saline.The device was in place for 12 hours and no rupture of membranes occurred during placement.No induction medications were given to the patient.When the balloon was removed the presenting part has moved upwards and breech presentation verified by ultrasound.Changing of the baby¿s position was not successful and c-section performed.In the doctor´s opinion there is nothing wrong with the device itself.The assessment from the doctor is that the baby changed from head-first presentation to breech presentation due to that the balloon has pushed the baby¿s head upwards.

Manufacturer Narrative

In review of the additional information, cook has concluded that there is no evidence indicating the device caused the baby to change positions.Movement of the baby in-utero may occur for numerous reasons, including the activities of the mother.Since no rupture of membranes occurred while the device was in place, it is not likely the device pushed the baby's head upward.A definitive reason for the baby's movement cannot be determined in this instance.

• 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: 7894121
• MDR Text Key: 120897615
• Report Number: 1820334-2018-02776
• Device Sequence Number: 1
• Product Code: PFJ
• UDI-Device Identifier: 00827002198913
• UDI-Public: (01)00827002198913(17)200328(10)7783756
• 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,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2020
• Device Model Number: N/A
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: 7783756
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR