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 Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E3: customer occupation = nurse manager.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.

Event Description

As reported, a 'cook cervical ripening balloon w/stylet' was placed with a stylet for cervical dilation.Approximately 10 hours later the device began to slip out of the cervix as progression of labor occurred; the device was then removed.The patient delivered the baby an unspecified amount of time later.After delivery, the patient's uterus ruptured.There was no reported malfunction with the 'cook cervical ripening balloon w/stylet' device.Additional information regarding event details, device malfunction, and outcome has been requested but is not available at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information received 03oct2023.(annex f) summary of event: as reported, a 'cook cervical ripening balloon w/stylet' was placed with a stylet for cervical dilation.Approximately 10 hours later the device began to slip out of the cervix as progression of labor occurred; the device was then removed.The patient delivered the baby an unspecified amount of time later.After delivery, the patient's uterus ruptured.There was no reported malfunction with the 'cook cervical ripening balloon w/stylet' device.No prostaglandins were administered in conjunction with the device.The estimated blood loss was 560ml.It is unknown if the patient received any blood transfusions.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the instructions for use (ifu) and quality control (qc) procedures were conducted during the investigation.A search of the device history record could not be completed due to lack of lot information from the user facility.A complaint history database search could not be completed due to lack of lot information from the user facility.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed product labeling.The ifu supplied with the device [t_j-ccrbs_rev3; 'cook cervical ripening balloon with stylet'] states the following in consideration of the reported failure mode: - '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 rupture' - 'potential adverse events: risk associated with use of the cook cervical ripening balloon and labor induction may include, but are not limited to: uterine rupture' the complaint device was not returned; therefore, no functional testing or visual inspections could be performed.Based upon the available information and results of the investigation, the cause for this event cannot be traced to the complaint device.The most probable cause of this event was related to patient factors.The appropriate personnel have been notified and cook will continue to monitor for similar events.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.

Event Description

Additional information received on 03oct2023: no prostaglandins were administered in conjunction with the device.The estimated blood loss was 560ml.It is unknown if the patient received any blood transfusions.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.

• 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 (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 17808081
• MDR Text Key: 324143312
• Report Number: 1820334-2023-01281
• Device Sequence Number: 1
• Product Code: PFJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Female