MAUDE Adverse Event Report: BAYER HEALTHCARE ESSURE; INSERT, TUBAL OCCLUSION

Catalog Number ESS305

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Hemorrhage/Bleeding (1888); Abdominal Distention (2601)

Event Date 07/09/2014

Event Type  malfunction  

Event Description

After deployment of the coils into the fallopian tube, there was a wire that remained in the uterine cavity and protruded out the cervix.Upon trying to remove the wire, the patient began to have increased bleeding and her abdomen began to distend.The representative from the company was called.Bleeding then obscured the hysteroscopic field.An exploratory laparoscopy was performed to rule out tube rupture or obvious perforation.A filche clip tubal ligation was performed in order to complete the sterilization.The patient had to be admitted for observation.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE; 1011 mccarthy blvd.; mipitas CA 95035
• MDR Report Key: 3982982
• MDR Text Key: 4635288
• Report Number: 3982982
• Device Sequence Number: 1
• Product Code: HHS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/11/2014

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
• Device Operator: Physician
• Device Catalogue Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR