MAUDE Adverse Event Report: BAYER ESSURE; TUBAL OCCLUSION

Model Number ESS305

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem Failure of Implant (1924)

Event Date 02/09/2017

Event Type  Injury  

Event Description

During an essure procedure for permanent birth control, the essure placement device did not separate from the procedural insert.The procedural insert anchored in place and prevented the device for placement, which had not separated from the insert, from being removed.

• Brand Name: ESSURE
• Type of Device: TUBAL OCCLUSION
• Manufacturer (Section D): BAYER
• MDR Report Key: 6345489
• MDR Text Key: 67937469
• Report Number: MW5067962
• Device Sequence Number: 1
• Product Code: HHS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ESS305
• Device Lot Number: C95080
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR