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

Model Number ESS305

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a physician in (b)(6) on (b)(6) 2016 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted on an unspecified date with lot number d29714.It was reported that essure implants were successfully inserted to both sides but after insertion it was noticed that some sharping head remained in catheter.Sample is available for examination.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and after the procedure it was noticed that some sharping head remained in catheter.This event, interpreted as suspicion of device breakage, is non-serious and unlisted in the reference safety information for essure.During difficult insertions, single cases have been reported of essure breakage.In the present case, essure insertion was performed successfully however after insertion it was noticed that some sharping head remained in the catheter.Since the suspected device breakage occurred during essure insertion procedure, a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident as although the device breakage did not lead to death or serious deterioration in health, this might have occurred under less fortunate circumstances.A product technical analysis and further information are expected.

Manufacturer Narrative

Follow up information was received on 05-jul-2016: this adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc global number (b)(4).Unique device identification: (b)(4).Quality-safety evaluation: since product was returned to us for investigation, we were able to conduct an investigation of the actual device involved in this complaint, visual inspection was performed and it was confirmed that all components are present.Ifu steps not were completed, final rollback not completed, due to this, the delivery wire (sharp point) is observed because it was not fully retracted by the physician, no damages were observed on delivery catheter, inner catheter and delivery wire bonds were cured.As part of the investigation process, ifu steps were completed by rqu and it was confirmed that delivery wire (sharp point) is retracted when ifu steps were completed.We were unable to confirm any quality defect or device malfunction at this time.We also conducted a review of the manufacturing batch record d29714 (production date 28-oct-2014 and expiration date 28-oct-2017) and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.There was no event reported which indicates a new technical failure mode for the device.Based on the available information no product quality defect was confirmed.Moreover, no medical events were reported, therefore the assessment of a relationship of medical events with a quality defect is not applicable.Since no medical events were reported, a batch investigation with respect to similar ae cases is not applicable.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted.The insertion was performed successfully; however after the procedure it was noticed that some sharping head remained in the catheter.This event was initially interpreted as suspicion of device breakage.However, a technical analysis was performed by the company with an investigation of the device involved in this complaint.According to the analysis the steps in essure's instructions for use (ifu) were not completed, final rollback not completed, due to this, the delivery wire (sharp point) was observed because it was not fully retracted by the physician, no damages were observed on delivery catheter, inner catheter and delivery wire bonds were cured.As part of the investigation process, ifu steps were completed by the quality unit and it was confirmed that delivery wire (sharp point) is retracted when ifu steps were completed.The analysis was unable to confirm any quality defect or device malfunction at this time.Based on the results of company analysis this case was updated and not regarded as other reportable incident.

Manufacturer Narrative

(b)(4).

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 5744337
• MDR Text Key: 48857430
• Report Number: 2951250-2016-00917
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: ESS305
• Device Lot Number: D29714
• Other Device ID Number: (01)10888853003051(17)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2016
• Initial Date FDA Received: 06/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/01/2016; 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2014
• 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