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 Problems Cervical Changes (1773); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Date of event: approximately two and a half weeks ago from (b)(6) 2021.Exact date is unknown.Occupation = director, labor and delivery.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, following the use of a cervical ripening balloon during mechanical induction, a patient required surgical intervention for a post-partum hemorrhage and prolapsed necrotic external cervical os.The device was digitally inserted one hour after the removal of cervidil.The patient had a bishop score of 3 and the fetal station was 2 at the time of device placement.The device was inflated using 80ml saline in each balloon.The device was expelled from the patient 6.5 hours after placement, at which time the cervix was dilated to 5cm.A vaginal exam performed at that time showed "normal" to minimal vaginal bleeding.Another vaginal exam performed later noted little to no bleeding and an intact cervix.The patient began to deliver 11.5 hours following the removal of the device.At that time, the physician remarked a "thick tissue" with a donut shape came out of the vagina, and the internal cervical os was folded inward.The delivery was performed successfully.Following delivery, the patient was taken to surgery to stop a post-partum hemorrhage.Follow-up examination days after the delivery noted that the patient's external cervical os was missing, and a pathology report determined the "thick tissue" was the patient's external cervical os.The patient is anticipated to have a potential for future pregnancy challenges as a result of the absence of an external cervical os.

Event Description

No new patient or event information has been received since the last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Event summary it was reported, ¿the patient suffered from post-partum hemorrhage and prolapsed necrotic external cervical os.¿ as reported, on an unknown date, a 33-year-old female patient of an unknown gestational age, required the use of a cook cervical ripening balloon w/stylet during mechanical induction.The operator reported that the patient had cervidil in place one hour prior to insertion of the device.At the time of placement, the operator reported that the patient had a bishop score of ¿3 and the fetal station was 2.¿ the device was inflated using 80ml saline in each balloon.After 6.5hours, the device was expelled, and the cervix was reported to be dilated to 5cm.A vaginal exam was performed at that time and showed ¿normal to minimal vaginal bleeding.¿ at an unknown time later, another vaginal exam was performed, and the operator reported ¿little to no bleeding and an intact cervix.¿ it was reported that 11.5 hours following the removal of the cook cervical ripening balloon, the patient began to deliver.During the delivery, the operator remarked ¿a thick tissue with a donut shape came out of the vagina and the internal cervical os was folded inward.¿ it was later determined that the ¿thick tissue¿ was the patients external cervical os.The patient was subsequently taken to surgery to stop post-partum hemorrhage.The patient outcome is unknown.No other adverse events were reported during this incident.Investigation - evaluation a document-based investigation was performed including a review of instructions for use (ifu) and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.There is no evidence to suggest the product was not made to specifications.Cook has not received a complaint for a similar product and a similar failure mode in which the complaint product was returned for physical examination.A review of the device history record could not be completed due to lack of lot information from the user facility.A review of the complaint history could not be completed due to lack of information from the user facility.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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: potential adverse events."maternal discomfort during and after insertion"."cervical laceration"."bleeding".The complaint was confirmed based on customer testimony.Based on the available information, it was concluded that the cause of the event cannot be traced to the complaint device.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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.

• 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: 11237918
• MDR Text Key: 231697767
• Report Number: 1820334-2021-00173
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• 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: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 33 YR