MAUDE Adverse Event Report: COOK INCORPORATED COOK; CATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR

Model Number G19891

Device Problems Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2019

Event Type  malfunction  

Event Description

The clinical nurse midwife placed the cook cervical ripening balloon successfully, then, when she attempted to remove the stylet, the blue plastic end cover/gripper came detached from the metal stylet, leaving nothing for the clinical nurse midwife to grasp to remove the stylet.She was unable to remove the stylet from the device, necessitating removing the entire device.A different brand cervical ripening balloon was then placed without difficulty.Manufacturer response for catheter, balloon, dilation of cervical canal prior to labor, cook (per site reporter).The representative is meeting with the clinical nurse specialist and planning on meeting with the staff.

• Brand Name: COOK
• Type of Device: CATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomingtom IN 47404
• MDR Report Key: 9144998
• MDR Text Key: 160943720
• Report Number: 9144998
• Device Sequence Number: 1
• Product Code: PON
• UDI-Device Identifier: 00827002198913
• UDI-Public: (01)00827002198913(17)220703(10)9855647
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: G19891
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: 9855647
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8030 DA