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

Catalog Number ESS305

Device Problems Bent (1059); Device Inoperable (1663); Improper or Incorrect Procedure or Method (2017); Device Damaged Prior to Use (2284)

Patient Problem No Information (3190)

Event Date 05/23/2014

Event Type  malfunction  

Event Description

Essure done on right side without difficulty.On to left side: essure tip appeared bad out of the package; bent during the case- lot # b53030; another device obtained from another lot number and this device tip bent when trying to insert-lot #b71770.A third device from another lot number obtained; this device deployed after insertion was complete but the release button had not been hit-lot #cs0003r; causing significant delay in case.From physician note regarding left side: "multiple attempts to pass essure coils were underwent.The first essure apparatus was noted to be bent due to the angle and multiple different angles were attempted.Four different essure apparatuses were attempted and a decision was made to abort the procedure at this time with the suspicion of tubal occlusion on the patient's left side versus pathologic tubal anatomy.At this time, view of the essure coil on the right side yielded complete expulsion of the essure coils into the uterine cavities.The essure coils were removed from the cavity.At this time, the decision was made to use the myosure apparatus to remove the endometrial mass.This was underwent without difficulty.".

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE; 1011 mccarthy blvd; milpitas CA 95035
• MDR Report Key: 3890000
• MDR Text Key: 4674417
• Report Number: 3890000
• 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: 06/04/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• 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
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OCCURRED DURING D&C, HYSTERSOCPY, POLYPECTOMY WITH; PLACE FOR 5 YEARS).; REMOVAL OF MIRENA IUD (MIRENA HAD EXPIRED - WAS IN; MYOSURE, FAILED ESSURE TUBAL STERILIZATION, AND
• Patient Age: 34 YR
• Patient Weight: 87