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

Model Number N/A

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

Patient Problem Chorioamnionitis (1777)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.

Event Description

(b)(4), patient (b)(6): chorioamnionitis noted possibly related to device.The cervical ripening balloon (crb) was inserted on (b)(6) 2016 at 10:37 (vaginal balloon 30 ml of saline, uterine balloon 60 ml of saline).Insertion was considered very easy.Pitocin was started at 10:42.The crb was removed at 16:36 for active labor.The patient was diagnosed with chorioamnionitis on (b)(6) 2016 (maternal fever > 100.4 degrees f, fetal tachycardia, foul smelling amniotic fluid).A spontaneous vaginal delivery occurred on (b)(6) 2016 at 02:17.The patient was treated with antibiotic therapy and discharged (b)(6) 2016.This event was marked as possibly related to the crb and possibly related to the induction procedure.It was noted that the event did not lead to serious deterioration in health and the site responded no to the following question: did the device malfunction or deteriorate in characteristics or performance? mother and baby were discharged from the hospital on (b)(6) 2016.The patient has completed and exited the study.

Manufacturer Narrative

(b)(4).Investigation - evaluation.A review of documentation, complaint history, device history record, specifications, and instructions for use (ifu) was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There was one other reported complaint for this lot number.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• 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
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6188716
• MDR Text Key: 62839307
• Report Number: 1820334-2016-01526
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: J-CRB-184000-CI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2017
• 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 Age: 26 YR
• Patient Weight: 88