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

Model Number ESS305

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This spontaneous case was reported by a physician and describes the occurrence of device breakage ("suspects there was a catheter breakage"), complication of device insertion ("suspects thre was a catheter breakage") and ("device insertion failed") in a (b)(6) female patient who had essure (batch no.Cs000x7) inserted for female sterilisation.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage and complication of device insertion.At the time of the report, the device breakage and complication of device insertion outcome was unknown.The reporter provided no causality assessment for device breakage and complication of device insertion with essure.Company causality comment: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a physician and describes the occurrence of device breakage ("suspects there was a catheter breakage"), the first episode of complication of device insertion ("suspects there was a catheter breakage") and the second episode of complication of device insertion ("device insertion failed") in a (b)(6) year-old female patient who had essure (batch no.(b)(4)) inserted for female sterilisation.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage, the first episode of complication of device insertion and the second episode of complication of device insertion.At the time of the report, the device breakage and the last episode of complication of device insertion outcome was unknown.The reporter provided no causality assessment for device breakage, the first episode of complication of device insertion and the second episode of complication of device insertion with essure.Most recent follow-up information incorporated above includes: on 24-jul-2017: quality safety evaluation of product technical complaint.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd.; whippany, NJ 07981-0915
• MDR Report Key: 6689775
• MDR Text Key: 79363248
• Report Number: 2951250-2017-02442
• Device Sequence Number: 1
• Product Code: HHS
• 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,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2018
• Device Model Number: ESS305
• Device Lot Number: CS000X7
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 40 YR