MAUDE Adverse Event Report: CONCEPTUS, INC. ESSURE; INSERT, TUBAL OCCLUSION

Catalog Number ESS305

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem Muscle Spasm(s) (1966)

Event Date 12/27/2013

Event Type  malfunction  

Event Description

Essure device was passed through the scope when the tip was found to be bent.A second device was opened and introduced through the scope into the tube and it became deformed in use.A third device was pulled to be used when the patient's tube was in spasm and could not be completed due to its condition.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): CONCEPTUS, INC.; 1011 mccarthy blvd; milpitas CA 95035
• MDR Report Key: 3560563
• MDR Text Key: 17925342
• Report Number: 3560563
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/02/2014

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
• Device Lot Number: B53030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2013
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DURING HYSTERCOPY TUBAL PROCEDURE
• Patient Age: 30 YR
• Patient Weight: 67