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

Model Number G19891

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(6).(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 during cervical ripening using a cook cervical ripening balloon w/stylet, ripening of the cervix was achieved.The device was removed and treatment was continued with an oxytocin infusion.Sometime later (unspecified time frame) in the course of treatment the patient required a cesarean section delivery.No additional consequences to the patient have been reported.Additional details regarding the patient and event have been requested, at this time no additional information has been provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.It was reported, the complaint device was used to achieve cervical ripening.After device removal, the physician continued with an oxytocin infusion.A cesarean delivery was determined to be necessary.No additional consequences to the patient have been reported, and no device malfunction was reported.Investigation ¿ evaluation.Reviews of complaint history, device history record (dhr), quality control data and the instructions for use(ifu) were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest this device was manufactured out of specification.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 production and quality documentation did not observe 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-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: "if spontaneous rupture of membranes occurs while the cook cervical ripening balloon (crb) is in place, there is a risk that the uterine balloon could become entangled in the umbilical cord, necessitating emergent cesarean delivery." it is known that the patient received oxytocin for an unspecified period to induce labor after the crb was removed.Using oxytocin to induce labor carries about a 25% risk of emergency c-section due to many factors such as fetal distress, premature placental detachment, uterine rupture, failure to progress to delivery, etc.It is not likely the complaint device contributed to the patient¿s need for a c-section delivery.There was no report of device malfunction, and in fact it was reported that cervical ripening was achieved with its use (the desired effect) and it was removed.It is likely that this event was related to the use of oxytocin for induction after the crb was removed coupled with some other underlying risk factors the patient had.Based on the available information, it was concluded that the cause of the event cannot be traced to the complaint device.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue our monitoring of 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

There is no new patient or event information to report.

• 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: 9782305
• MDR Text Key: 189445925
• Report Number: 1820334-2020-00539
• Device Sequence Number: 1
• Product Code: PFJ
• UDI-Device Identifier: 00827002198913
• UDI-Public: (01)00827002198913(17)210529(10)8913769
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2021
• Device Model Number: G19891
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: 8913769
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention