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

Catalog Number J-CRB-184000

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

Patient Problem Fever (1858)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported during a labor induction procedure, a cook® cervical ripening balloon was used on the patient.The physician used a speculum to gain cervical access and then cleaned the patient's cervix with cleaning solution to prepare for device insertion.The physician inserted the cervix and both balloons entered the cervical canal.The physician inflated the uterine balloon with 40 ml of normal saline and the device was pulled back against the internal cervical os.The vaginal balloon was then inflated with 20 ml of saline.The physician added more fluid to each balloon in turn, in 20 ml increments until the uterine balloon and vaginal balloon contained 80 ml of saline.The physician later removed the device from the patient.The patient had a postoperative fever after and was at a temperature of 37.2°.By active treatment symptom relief, the patient was returned to normal condition.The patient has since recovered and was discharged from the hospital.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.No adverse effects or consequences were reported to the patient due to this occurrence.

Manufacturer Narrative

Investigation: evaluation: the device was not returned for an analysis and no photos were provided.Without the complaint device, a physical investigation was not able to be completed.A document based investigation has been performed which includes a review of complaint history, the device history record, the instructions for use, and quality control data.The j-crb-184000 is used for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction.According to the instructions for use (ifu), the product should not be left indwelling for a period greater than 12 hours.There is no indication that the device was unsterile or packaging was damaged prior to use.Per the ifu, sterile package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.There is no information stating if the patient had a vaginal or cesarean delivery after removal of the product.It should be noted the patient temperature postpartum is 37.2 which is 98.96 in fahrenheit.Temperatures vary among individuals and there is no baseline data for this patient that would indicate this temperature is unusually high.Per the cdc.Gov website, ¿the 42 code of federal regulations parts 70/71 final rule defines a fever as a measured temperature of 100.4 °f [38 °c] or greater.¿ the device history record was reviewed and noted one non-conformance for 2 items with the labels applied incorrectly.No other non-conformances were noted.A review of complaint history revealed there has been no other complaint associated with the complaint device lot number: (7990094).Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.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.There is no evidence that suggests any causal relationship between the j-crb-184000 and the patient¿s alleged fever.Based on the provided information a definitive root cause cannot be established.The appropriate cook personnel have been notified of this event.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed 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.

• Brand Name: COOK® CERVICAL RIPENING BALLOON
• Type of Device: PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7172118
• MDR Text Key: 96633003
• Report Number: 1820334-2018-00015
• Device Sequence Number: 1
• Product Code: PFJ
• UDI-Device Identifier: 00827002481497
• UDI-Public: (01)00827002481497(17)200614(10)7990094
• Combination Product (y/n): N
• PMA/PMN Number: K131206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-CRB-184000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 DA
• Patient Weight: 60