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

Catalog Number J-CRBS-184000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E3: customer occupation = clinic 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 used for induction of labor on an unknown number of patients.It was reported that these patients experienced umbilical cord prolapse (ucp) in conjunction with the use of the device.These patients then required cesarean sections due to the cord prolapse.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Event description: as reported, a 'cook cervical ripening balloon w/stylet' was used for induction of labor on an unknown number of patients.It was reported that these patients experienced umbilical cord prolapse (ucp) in conjunction with the use of the device.These patients then required cesarean sections due to the cord prolapse.Additional information regarding event details, patient anatomy and outcome has been requested but, no additional information has been provided.Investigation - evaluation: reviews of instructions for use (ifu) and quality control procedures were conducted during the investigation.The complaint devices were not returned for investigation.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of complaint history records could not be completed due to lack of lot information from the user facility.Review of the customer testimony and relevant manufacturing documents does not indicate that the device was manufactured out of specifications and does not suggest items in the lot or similar devices in the field or in house are nonconforming.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: intended use "the cook cervical ripening balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction." contraindications "prolapsed umbilical cord".A definitive cause of the events could not be determined from the available information.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.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

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 17011041
• MDR Text Key: 316032284
• Report Number: 1820334-2023-00668
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2023
• 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): Required Intervention
• Patient Sex: Female