MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

Model Number ESS305

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a physician in united states on 13-jan-2016 which refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) lot number d06939 (expiration date 28-sep-2017) inserted on (b)(6) 2016 for contraception.Physician inserted essure on one side just fine.When he was inserting the next one on the right side it would not deploy.It stayed attached to inserter.He pulled so hard on it with a grasper to remove it that it broke and part of coil was still in patient.He was going to do a novasure procedure immediately after essure insertion but decided against it.He was concerned about bleeding so he was keeping a check on patient and will send her home if nothing occurs.She was doing okay at time of this report.He was going to offer her a hysterectomy.Follow-up received on 15-jan-2016: physician spoke to the patient on (b)(6) 2016 and she was seems to be fine.Follow up information received on 19-jan-2016: the physician spoke to the patient and she was doing fine.He said he has inserted essure many times and this never happened to him before.He saw black mark at insertion and rolled back and the unit would not release at all.He attempted to remove the coil and inserter but pulled hard and it broke.He thought the entire coil, part of inserter and the plastic sheath were still inside endometrial cavity.Follow up 11-feb-2016: no new information was provided.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and during insertion procedure, the physician pulled so hard with a grasper to remove it that it broke and part of coil is still in patient.The physician was going to offer a hysterectomy.This event, interpreted as device breakage, was considered non-serious and unlisted in the reference safety information for essure.During difficult insertion/removals, single cases have been reported of essure breakage.Based on its nature, a causal relationship with suspect insert cannot be excluded.This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Additionally, non-serious events were reported.Further information (device breakage questionnaire) and product technical analysis are being sought.

• Brand Name: ESSURE
• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; milpitas CA
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 1011 mccarthy blvd.; milpitas CA 95035
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd., p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 5434697
• MDR Text Key: 38777247
• Report Number: 2951250-2016-00095
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: ESS305
• Device Lot Number: D06939
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2016
• 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 Age: 30 YR