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

Catalog Number J-CRBS-184000

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Occupation: other healthcare professional.(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 that during an unblinded randomized trial of methods for labor induction, the patient had a cook cervical ripening balloon placed.After an unspecified time interval, the patient required a forceps delivery, and experienced a 1.3l blood loss.The patient's post-partum hemorrhage was treated with syntocinon 10iu intramuscularly, syntocinon 40iu intravenously, and tranexameic acid 1gm intravenously, with resolution.The physician stated that there was no causal relationship between the events and the cook cervical ripening balloon.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.

Event Description

The following information was provided on 13feb2019 via email correspondence from the chief investigator of the study.As explained to you today, the reason why you have received many e-mails regarding adverse events related to participants in the trial is because all these were categorized (in error) as serious adverse events (saes) rather than just adverse events (aes).These adverse events do not have a causal relationship with the use of the cook balloon.Although these adverse events are erroneously listed as saes, our sponsor is legally bound to inform the manufacturers of the device (cook medical).

Manufacturer Narrative

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.

• 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: 8302158
• MDR Text Key: 134904786
• Report Number: 1820334-2019-00294
• Device Sequence Number: 1
• Product Code: PFJ
• Combination Product (y/n): N
• PMA/PMN Number: K131206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Weight: 57