MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Break (1069); Premature Activation (1484); Uncoiled (1659); Separation Failure (2547); Activation, Positioning or Separation Problem (2906)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 03/21/2018

Event Type  malfunction  

Event Description

This spontaneous case was reported by an other and describes the occurrence of device breakage ("the coil unraveled with part inside the patient (lot number he012ec), the other part attached to the device which was now outside the hysteroscope") in a (b)(6) female patient who had essure (batch no.He012ec) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "doctor performed a hysteroscopy and essure tubal ligation and ablation" on (b)(6) 2018.On (b)(6) 2018, the patient had essure inserted.On the same day, the patient experienced device breakage (seriousness criterion medically significant), complication of device insertion ("the coil unraveled with part inside the patient (lot number he012ec), the other part attached to the device which was now outside the hysteroscope") and device deployment issue ("doctor placed the device within the tube, deployed the coil but the end of the coil remained connected to the device").At the time of the report, the device breakage, complication of device insertion and device deployment issue outcome was unknown.The reporter considered complication of device insertion, device breakage and device deployment issue to be related to essure.The reporter commented: the lot number for the 2nd box is he012xa.The coil was deployed but part of the coil was not within the tube so it was retrieved with a grasper and removed from the patient.They opened the other package from the box and inserted successfully.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.

Manufacturer Narrative

This spontaneous case describes the occurrence of device breakage ('the coil unraveled with part inside the patient (lot number he012ec), the other part attached to the device which was now outside the hysteroscope') in a 40-year-old female patient who had essure (batch no.He012ec,he012xa) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "doctor performed a hysteroscopy and essure tubal ligation and ablation" on (b)(6) 2018 and device deployment issue "doctor placed the device within the tube, deployed the coil but the end of the coil remained connected to the device" on (b)(6) 2018.On (b)(6) 2018, the patient had essure inserted.On (b)(6) 2018, the patient experienced device breakage (seriousness criterion medically significant) and complication of device insertion ("the coil unraveled with part inside the patient (lot number he012ec), the other part attached to the device which was now outside the hysteroscope").At the time of the report, the device breakage and complication of device insertion outcome was unknown.The reporter considered complication of device insertion and device breakage to be related to essure.The reporter commented: the lot number for the 2nd box is he012xa.The coil was deployed but part of the coil was not within the tube so it was retrieved with a grasper and removed from the patient.They opened the other package from the box and inserted successfully.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-jun-2019:quality-safety evaluation of ptc (product technical complaint).Incident: we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7439494
• MDR Text Key: 105775223
• Report Number: 2951250-2018-01864
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: ESS305
• Device Lot Number: HE012EC,HE012XA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR