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

Model Number ESS305

Device Problems Difficult to Insert (1316); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a medical doctor in united states on (b)(6) 2014 which refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2014 with lot number c03097.It was reported that device fell apart when inserting.No injury to the patient.Bilateral placement achieved.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and the device fell apart when inserting.This event, interpreted as device breakage and complication of device insertion, is non-serious.Device breakage is unlisted in the reference safety information for essure while complication of device insertion is listed.During difficult insertions, single cases have been reported of essure breakage.In this case, the device breakage occurred during essure insertion procedure.Therefore, a causal relationship between the reported event and essure 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.A product technical analysis and follow up information have been requested.

Manufacturer Narrative

Follow up 13.Jan.2015: ptc investigation results were provided.(b)(4).Final assessment: failure mode/mechanism: the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube.The insert's outer coils expand to conform to the fallopian tube, acutely anchoring itself until the insert elicits tissue ingrowth.After the first roll back is completed and the button is pressed, user attempts to reposition the device could lead to detachment difficulty, premature deployment, or improper device function.If all ifu steps have not been completed, user attempts to reposition or remove the catheter assembly could lead to either a stretching or breakage of the micro-insert or a part of the catheter.If the physician attempts to remove a deployed micro-insert that is located within the fallopian tube by pulling on the outer coil of the micro-insert with a grasper, this action could also lead to breakage of the outer coil of the micro-insert.Since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert, outer catheter, the inner catheter, and all parts within the handle assembly.In this case, we conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We were unable to confirm any quality defect or device malfunction at this time.Final risk classification risk category v medical assessment: this product technical complaint was initiated due to reported product technical issue (breakage).The ae case also refers to a usability issue (complicated insertion).However, at this point in time no adverse events were reported.Since no adverse events have been reported, a batch investigation with respect to similar ae cases is not applicable.The batch documentation of the reported batch was reviewed.No complaint sample was provided for a technical investigation.The technical assessment concluded unconfirmed quality defect and noted that the possibility of micro-insert breaking during the procedure is an anticipated event.However, an assessment regarding a causal relationship between a potential quality defect and an adverse event is not possible as no adverse event was reported.Follow-up received on 26-jan-2015 and 29-jan-2015.According to the reporter, the device was defective and it was received as such by the office.In this case, the device broke as they were trying to insert into the introducer.The problem was observed before the physician attempted to insert the device into patient.The physician noticed right away and didn't attempt to use it.There was no adverse event.The physician disposed the device, so it will not be returned to the company.Company causality comment: this spontaneous medically confirmed case report refers to a female patient where device fell apart when inserting into the introducer.It occurred before inserting essure (fallopian tube occlusion insert) in the patient (previously stated that it occurred during insertion).This event, interpreted as device breakage is non-serious.Device breakage during insertion is considered unlisted according to essure's reference safety information.The event complication of device insertion was removed upon follow up information.In this case, the device breakage occurred as the physician was trying to insert into introducer, before attempting to insert into patient.Considering the nature of event it was considered related to essure.Upon follow up information, the case was regarded as non-incident since the device breakage occurred before inserting it into patient.An updated product technical analysis is expected.

• 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: 4393356
• MDR Text Key: 5126068
• Report Number: 2951250-2015-00010
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: ESS305
• Device Lot Number: C03097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR