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

Model Number	J-CRBS-184000
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Cook cervical ripening balloon end broke off and the other part stayed in patient.Patient had a c-section to remove the rest of the balloon.Patient was being induced and catheter was being used per policy/protocol.

• Brand Name: COOK CERVICAL RIPENING BALLOON WITH STYLET
• Common Device Name: CATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR
• Manufacturer (Section D): COOK MEDICAL; bloomington IN 47404
• MDR Report Key: 18667809
• Report Number: MW5151170
• Device Sequence Number: 17924305
• Product Code: PFJ
• UDI-Device Identifier: 00827002198913
• UDI-Public: 0100827002198913172611161015760869
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: J-CRBS-184000
• Device Catalogue Number: G19891
• Device Lot Number: 15760869
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White