MAUDE Adverse Event Report: COOK MEDICAL COOK MEDICAL; COOK CERVICAL RIPENING BALLOON

Model Number	REF J-CRBS-184000
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During induction of labor, a cook catheter cervical ripening balloon was utilized.After inserting the catheter and inflating the balloon, the balloon burst and the catheter could no longer be used.The patient continued with an uneventful labor and delivery of newborn.

• Brand Name: COOK MEDICAL
• Common Device Name: COOK CERVICAL RIPENING BALLOON
• Manufacturer (Section D): COOK MEDICAL; bloomington IN
• MDR Report Key: 7221572
• Report Number: MW5074891
• Device Sequence Number: 1556640
• Product Code: HDY
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2018

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: REF J-CRBS-184000
• Device Catalogue Number: REF G19891
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 90