MAUDE Adverse Event Report: COOK UROLOGICAL INC. COOK CERVICAL RIPENING BALLOON; DILATOR, CERVICAL

Catalog Number J-CRB-184000

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Chorioamnionitis (1777)

Event Date 03/21/2014

Event Type  Injury  

Event Description

A study site reported that a (b)(6) female primigravida underwent labor induction with a cervical ripening balloon (crb) and pitocin on (b)(6) 2014.Crb was inserted on (b)(6) 2014 at 12:38 (vaginal balloon 60 ml of saline, uterine balloon 30 ml of saline).Insertion of crb was considered difficult.Crb was removed on (b)(6) 2014 at 17:25 due to complication of balloon: "balloon causing pain/pressure".Received epidural anesthesia on (b)(6) 2014 beginning at 17:48.Spontaneous vaginal delivery on (b)(6) 2014 at 01:38.Intrapartum chorioamnionitis symptoms began on (b)(6) 2014 (maternal fever greater than 100.4 degrees f, sustained maternal tachycardia, fetal tachycardia, foul smelling amniotic fluid).The pt was treated with antibiotic therapy.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 that the device did not malfunction or deteriorate in characteristics or performance.The pt was discharged from hospital on 03/23/2014.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

• Brand Name: COOK CERVICAL RIPENING BALLOON
• Type of Device: DILATOR, CERVICAL
• Manufacturer (Section D): COOK UROLOGICAL INC.; spencer IN 47460
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4452574
• MDR Text Key: 5423428
• Report Number: 1820334-2015-00052
• Device Sequence Number: 1
• Product Code: HDY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/21/2014
• Event Location: Hospital
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 28 YR