MAUDE Adverse Event Report: COOK, INC. COOK CERVICAL RIPENING BALLOON; CATHETER, BALLOON, DILATION OF CERVICAL CANAL

Catalog Number J-CRBS-184000

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2015

Event Type  malfunction  

Event Description

A (b)(6) patient in labor and delivery.Md noted that stylet on the cook catheter cervical ripening balloon came apart in pieces while withdrawing the stylet from the catheter following placement.The small white bead at non-catheter tip popped off and the plastic stylet holder slid off the stylet wire.This may have been due to stylet bending, it was noted to have been difficult to withdraw from catheter.There was no known harm to patient.

• Brand Name: COOK CERVICAL RIPENING BALLOON
• Type of Device: CATHETER, BALLOON, DILATION OF CERVICAL CANAL
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5060378
• MDR Text Key: 25156429
• Report Number: 5060378
• Device Sequence Number: 1
• Product Code: PFJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/01/2018
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: 5841157
• Other Device ID Number: G19891
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR