MAUDE Adverse Event Report: COOK UROLOGICAL INC COOK CERVICAL RIPENING BALLOON WITH STYLET; HDY DILATOR, CERVICAL

Catalog Number J-CRBS-184000

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Type  Injury  

Event Description

While attempting to place the balloon in a multiparous female who was an inductions of labor for intrauterine growth restriction (iugr) led to a significant cervical hemorrhage.After inflating the uterine balloon with the initial amount, prior to inflating the vaginal balloon, there was a large gush of blood from the vagina.The fetal heart tracing remained intact and the pts cervix was notably more effaced and dilated.Pt continued to hemorrhage, the cervix was inspected and there were abrasions noted at 3:00 and 9:00.Ring forceps were applied, the pt was monitored, and when the ring forceps were removed, the bleeding had abated.The pt lost approximately 1500cc of blood but had a successful nsvd.

Manufacturer Narrative

Event evaluation: still under investigation.

• Brand Name: COOK CERVICAL RIPENING BALLOON WITH STYLET
• Type of Device: HDY DILATOR, CERVICAL
• Manufacturer (Section D): COOK UROLOGICAL INC; spencer IN 47460
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3736027
• MDR Text Key: 4276802
• Report Number: 1820334-2014-00140
• Device Sequence Number: 1
• Product Code: HDY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-CRBS-184000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 03/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other