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

Catalog Number J-CRBS-184000

Device Problems Fluid/Blood Leak (1250); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2022

Event Type  malfunction  

Event Description

Patient thought water broke, per protocol nursing removed cooks cervical ripening catheter.Upon placement, uterine balloon filled with 80ml normal saline, vaginal balloon filled with 80ml normal saline.On removal, uterine balloon deflated with removal of 80ml normal saline, then vaginal balloon however was only able to remove 40ml until met resistance.Cooks catheter removed, vaginal balloon on inspection leaking fluid below balloon.Fda safety report id# (b)(4).

• Brand Name: CERVICAL RIPENING BALLOON
• Type of Device: CATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR
• Manufacturer (Section D): COOK INCORPORATED; bloomington IN 47402 4195
• MDR Report Key: 15588630
• MDR Text Key: 301730856
• Report Number: MW5112542
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: 14679379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White