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

Model Number ESS305

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 03/16/2018

Event Type  malfunction  

Event Description

This spontaneous case was reported by an other health professional and describes the occurrence of device breakage ("outer sheath was coming off inside he patient") and complication of device insertion ("physician then ceased using the device and changed the procedure") in a (b)(6) old female patient who had essure (batch no.He0134n) inserted.On (b)(6) 2018, the patient had essure inserted.In (b)(6) 2018, 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 complication of device insertion and device breakage with essure.The reporter commented: there was no known impact or consequence to the patient.The event occurred in operating room of a hospital; the insertion procedure was being performed via hysteroscopy.According to the reporter there was no known impact or consequence to the patient.Further information (device breakage questionnaire) and sample will be requested.

Manufacturer Narrative

This case was initially received via regulatory authority (fda on 27-mar-2018.The most recent information was received on 10-jan-2019.This spontaneous case was reported by a health professional and describes the occurrence of device breakage ("outer sheath was coming off inside the patient") in a 23-year-old female patient who had essure (batch no.He0134n, udi no.(b)(4)) inserted.The occurrence of additional non-serious events is detailed below.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 ("physician then ceased using the device and changed the procedure").The patient was treated with surgery (laparoscopy).On (b)(6) 2018, the device breakage and complication of device insertion had resolved.The reporter provided no causality assessment for complication of device insertion and device breakage with essure.The reporter commented: there was no known impact or consequence to the patient.The event occurred in operating room of a hospital; original intended procedure: hysteroscopy.Physician ceased using the device and changed the procedure (laparoscopy).Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended on 11-jan-2019 for the following reason: malfunction field updated.No new follow-up information was received from the reporter.Incident: we received a lot number/returned sample 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.

Manufacturer Narrative

This case was initially received via regulatory authority (fda).The most recent information was received on 18-apr-2018.This spontaneous case was reported by an other health professional and describes the occurrence of device breakage ("outer sheath was coming off inside he patient") in a 23-year-old female patient who had essure (batch no.He0134n) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2018, the patient had essure inserted.On (b)(6) 2018, the patient experienced device breakage (seriousness criteria medically significant) and complication of device insertion ("physician then ceased using the device and changed the procedure").The patient was treated with surgery (laparoscopy).On (b)(6) 2018, the device breakage and complication of device insertion had resolved.The reporter provided no causality assessment for complication of device insertion and device breakage with essure.The reporter commented: there was no known impact or consequence to the patient.The event occurred in operating room of a hospital; original intended procedure: hysteroscopy.Physician ceased using the device and changed the procedure (laparoscopy).Quality-safety evaluation of ptc: since product was returned to us for this complaint, we were able to conduct an investigation of the returned product.As received, valved introducer and delivery catheter still with the implant attached were available.Implant was still attached to delivery catheter and with presence of external fluids.Outer catheter was inspected, it was not observed to be broken, however a small section with external material was observed.The external material was removed to verify this was not a broken or damaged section of outer catheter.Outer catheter had no damage or broken section.Based on previous observations the reported quality defect is unconfirmed.Since ifu steps were not performed by complainant, the device was activated to verify proper functionality, ifu steps were completed and implant was released as expected.All internal components of handle were located properly.Inner catheter had no evidence of breakage or damage.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.The results of the returned sample investigation showed no quality defect or malfunction.Most recent follow-up information incorporated above includes: on 18-apr-2018: device breakage questionnaire received: reporter stated that breakage occurred during essure placement on (b)(6) 2018; the outer sheath was coming off inside the patient.At the same day, essure was removed laparoscopically and pieces were retrieved.The outcome was reported as recovered/resolved.On (b)(6) 2018: ptc result the results of the returned sample investigation showed no quality defect or malfunction.The initial information provided indicated that there was no impact or consequence to the patient.However, upon follow up information it was mentioned that breakage occurred and a removal procedure was necessary (laparoscopy).Both initial and follow-up information were considered during the returned complaint sample investigation.The conclusion of the investigation showed the outer and inner catheter had no damage or broken section which would be consistent with the follow-up information about removal (since the insert was never deployed).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.The results of the returned complaint sample investigation resulted in an unconfirmed quality defect.

• 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: 7398045
• MDR Text Key: 105161803
• Report Number: 2951250-2018-01477
• 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: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: ESS305
• Device Lot Number: HE0134N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR