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

Model Number G19891

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 07/31/2021

Event Type  malfunction  

Event Description

Patient noted clear fluid leaking, cook catheter in place.Rupture of membranes was assumed at 03:20.At 0802, rn and cnm went to deflate the balloon and only 20ml was obtained out of the 80 ml placed.Md checked patient and stated the vaginal balloon was completely deflated and membranes are intact.Assume vaginal balloon ruptured.At 20:19, uterine balloon deflated and removed.Rn went to test balloon and there were holes in the balloon releasing fluid.Patient was started on iv antibiotics for presumed rupture of membranes.

• Brand Name: COOK CERVICAL RIPENING BALLOON WITH STYLET
• Type of Device: CATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12318007
• MDR Text Key: 266388465
• Report Number: 12318007
• Device Sequence Number: 1
• Product Code: PFJ
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G19891
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: 14012664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA
• Patient Weight: 79