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

Model Number J-CRBS-184000

Device Problems Material Fragmentation (1261); Difficult to Remove (1528)

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

Event Date 01/30/2021

Event Type  malfunction  

Event Description

Cervical cook balloon was removed by rn.Vaginal balloon came out intact, uterine balloon sheared off from vaginal balloon.Rn notified md, md and rn unable to remove deflated uterine balloon from uterus.Ob hosp consulted, unable to remove balloon fragment.Epidural placed, uterine balloon fragment removed by md.No harm noted to patient.Fda safety report id # (b)(4).

• Brand Name: COOK CERVICAL RIPENING BALLOON WITH STYLET
• Type of Device: CATHETER, BALLOON, DILATION OF CERVICAL CANAL PRIOR TO LABOR
• Manufacturer (Section D): COOK INC.; bloomington IN 47402
• MDR Report Key: 11595458
• MDR Text Key: 243527674
• Report Number: MW5100414
• Device Sequence Number: 1
• Product Code: PFJ
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: J-CRBS-184000
• Device Catalogue Number: G19891
• Device Lot Number: 13514796
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24 YR