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 02/08/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: oxytocin was used after the device was removed from the patient.(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 cook cervical ripening balloon w/stylet was inserted on (b)(6) 2018 at 11:20 am.On (b)(6) 2018 at 2:50pm, the ripening balloon was removed and labor induction was started with oxytocics.A complicated uterine rupture then happened affecting the right anterolateral and posterolateral walls of the uterus and a hemorrhage started, leading to an emergency c-section (b)(6) at 1:15am.It was reported, ¿ balloon discarded.Red code: repair of lesions, stop the bleeding, patient in reanimation¿.Requests were made for additional information regarding the outcome of the mom and baby, oxytoxin protocol being used, obstetric and gynecological history of the patient prior to this pregnancy and birth, complications of this pregnancy, if the patient received any medications from the time the device was inserted until it was removed, and the providers opinions regarding the reason for the spontaneous rupture; however, the information has not been provided.Per the instructions for use (ifu) ¿the device is not intended to be in place for longer than 12 hours.Time the placement of the device 12 hours prior to the planned induction¿.Under warnings it states ¿ the product should not be left indwelling for longer than 12 hours¿.Under the potential adverse events listed in the ifu, uterine rupture is listed as a risk associated with the device and labor induction.

Manufacturer Narrative

Investigation ¿ evaluation.The cook cervical ripening balloon w/stylet balloon was not returned for evaluation and no photos have been provided.Without the complaint device, a physical investigation was not able to be completed.A review of complaint history, the device history record, instructions for use, and trends was conducted.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.A review of the device history record found no non-conformance issues likely related to the failure mode noted in the complaint.A review of complaint history for this product lot number combination found no other complaints have been reported.The j-crbs-184000 is used for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction.According to the time frame given by the customer, the device was indwelling over 23 hours.Per the instructions for use (ifu), this product should not be left indwelling longer than 12 hours.There is no information regarding what was used to inflate the device.Per the ifu, always inflate the balloon with a sterile saline.There is no information about device placement and monitoring.The ifu states, once the uterine balloon is inflated, pull the device back until the uterine balloon is against the internal cervical os.There is no information regarding inflation of the balloons or device preparation.The patient¿s uterine rupture occurred after removal of the j-crbs-184000 and following initiation of the oxytocic medication.There is no patient information or procedural information.Uterine rupture can occur for many reasons (e.G., induced labor, overstretched uterus, previous c-section, fetus in the wrong position).It is not known if the patient has a predisposition to bleeding tendencies.There is no evidence to suggest there was a causal relationship between the uterine rupture and the j-crbs-184000.A review for relevant references in the ifu was conducted.Uterine rupture is a known potential adverse event.It is also noted in the warnings section of the ifu that concomitant use of the cervical ripening balloon with exogenous prostaglandin may increase the risk of adverse events, including uterine rupture.The instructions for use contains the following related information: 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.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.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.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.Note: if the membranes rupture spontaneously before removal of the device, it is recommended to deflate the balloons and remove the device to facilitate active labor management.The cause of the reported uterine rupture is unknown.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7343087
• MDR Text Key: 102577296
• Report Number: 1820334-2018-00463
• Device Sequence Number: 1
• Product Code: PFJ
• UDI-Device Identifier: 00827002198913
• UDI-Public: (01)00827002198913(17)201012(10)8290471
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-CRBS-184000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2018
• Date Device Manufactured: 10/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR