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

Catalog Number	J-CRB-184000
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Fever (1858)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a patient developed a fever following the use of a 'cook cervical ripening balloon'.Upon removal from the package, no damage to the device was noted.The nurse was able to place the device in 3-5 minutes.After the device was indwelling 12-14 hours, it was noted that the patient developed a fever.The device was removed, and artificial rupture of membranes (arom) was performed and oxytocin was administered.The patients hemogram (cbc) test was found to be elevated and it was decided that the patient would be converted from vaginal delivery to cesarean section.The patient's fever was treated with antibiotics.The patient was not cultured to determine the cause of the fever.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: customer (person) street = (b)(6).E3: customer occupation = unknown.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation evaluation.As reported, a patient developed a fever following the use of a 'cook cervical ripening balloon'.Upon removal from the package, no damage to the device was noted.The nurse was able to place the device in 3-5 minutes.After the device was indwelling 12-14 hours, it was noted that the patient developed a fever.The device was removed, and artificial rupture of membranes (arom) was performed and oxytocin was administered.The patients hemogram (cbc) test was found to be elevated and it was decided that the patient would be converted from vaginal delivery to cesarean section.The patient's fever was treated with antibiotics.The patient was not cultured to determine the cause of the fever.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control (qc) procedures, as well as inspection of unused product were conducted during the investigation.Visual inspection of the returned complaint device(s) was also conducted.Eight, unopened, 'cook cervical ripening balloon' was returned for investigation.There was no damage to the packages or seals.Review of the device history record, complaint history, and quality control documents does not indicate that the device was manufactured out of specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) found no related non-conformances reported for lot.A complaint history database search showed one other related complaints associated with the failure mode for the complaint device for lot.Due to the individual nature of the manufacturing and inspection process for the devices in the lots, it is unlikely that these events are an indication of device issue within the entire lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling; the ifu [t_j-ccrb_rev3; 'cook cervical ripening balloon with stylet'] supplied with the device states the following in consideration of the reported failure mode: - warnings: "the product should not be left indwelling for a period greater than 12 hours." - instructions for use: "note: 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." the complaint was confirmed based on customer testimony.Based on the available information, the cause for this event cannot be traced to the complaint device.The most probable cause of this event was related to the user's failure to follow instructions.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 or Problem 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
• Common Device Name: 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: 18925006
• Report Number: 1820334-2024-00373
• Device Sequence Number: 13102473
• Product Code: PFJ
• UDI-Device Identifier: 00827002481497
• UDI-Public: (01)00827002481497(17)251108(10)15058206
• Combination Product (Y/N): N
• PMA/510(K) Number: K131206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2025
• Device Catalogue Number: J-CRB-184000
• Device Lot Number: 15058206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female