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

Model Number ESS305

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 03/20/2014

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a physician in united states on (b)(6) 2014 which refers to a (b)(6) female pt who had essure (fallopian tube occlusion insert) inserted and experienced three coils of one device broke off.No info given on pt's history, past drugs, concurrent conditions and concomitant medication received.On (b)(6) 2014 the pt had essure (fallopian tube occlusion insert) inserted, and three coils of one device broke off.The doctor went in a grasping tool, and as he was bringing the piece through the cervix and into the vagina when it disappeared and he lost sight of it.The pt had an x-ray of her abdomen and of a bag of trash to see if the coils could be found and there was no foreign body in the uterus or vagina.No outcome was provided.No causality assessment was given.Follow-up received on (b)(6) 2014.

Manufacturer Narrative

F/u from 30-jun-2014: the required number of f/u attempts has been completed, with no response to date.Follow up from 30-jun-2014: ptc result.Ptc global number: 2014-007355/1.Final assessment: when a term like "broke" is used when describing a device event, it is difficult to determine the true nature of the event from the complaint description alone.Unless additional detail is provided in the event description, it is difficult to determine if the reporter is describing an event where the micro-insert actually broke into individual pieces, or if the micro-insert bent or stretched into an unintended shape, and hence was considered by the reporter to be "broken".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, the outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all are within manufacturing specs.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.Since no product was returned for investigation, we cannot confirm this quality complaint; however, based on the complaint description provided, we are able to conclude that a quality issue is plausible.It is possible during the mfg assembly process a small gap was left between the inner coil and inner catheter (they should be butted together during assembly).When the outer coil of the micro-insert is wound down a small portion of the coil can become trapped in the gap.If a device has this issue, when the physician presses the button to release the micro-insert, the outer coil may sever itself as it is being deployed from the catheter.In typical situations, this severing occurs inside the catheter prior to the pieces being deployed from the catheter.The severing of the coils inside the catheter does not pose a significant risk to the health of the patient.Medical assessment: this case reported breakage and difficult to use but these events are not necessarily indicative of a quality defect.No batch number was reported.Neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible without a batch number.No complaint sample was provided for a technical investigation.At time of this medical assessment the technical investigation concluded "unconfirmed quality defect - but plausible" with a final risk category iv, a defect which does not pose a hazard to patient's health as the severing of the coils does not pose a significant risk to the health of the patient.According to the technical assessment a quality defect was plausible and based on the provided information the defect type corresponds to the following meddra llt device breakage.In summary, based on the available information of the device breakage and a product defect, a causal relationship cannot be excluded.Company causality comment: spontaneous report, medically confirmed.Device breakage described as three coils of one device broke off was identified at day of essure placement in a (b)(6) year-old female patient.A removal attempt of broken device failed.It was reported that the treating physician was bringing the piece through the cervix and into the vagina when it disappeared and he lost sight of it.Findings of a performed x-ray did not show any piece of essure in abdomen.No foreign body was identified in uterus or vagina.Event three coils of one device broke off is classified serious due to medical importance (required removal intervention) and is unlisted in the reference safety information for essure (fallopian tube occlusion insert).Event is regarded as near-incident.Reporter did not comment causality.During difficult insertion or removals, single cases have been reported of ess breakage.In this particular case, device breakage occurred in close temporal association with insertion procedure.Considering a positive temporal relationship and based on available information, a causal relationship between device breakage and essure cannot be excluded.According to the ptc assessment a quality defect was plausible and based on the provided information the defect type corresponds to the following meddra llt device breakage.In summary, based on the available information of the device breakage and a product defect, a causal relationship cannot be excluded.

Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

• 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: 3767766
• MDR Text Key: 15206052
• Report Number: 2951250-2014-00114
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2017
• 2 Devices were Involved in the Event: 1 2

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 Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2014
• Initial Date FDA Received: 04/17/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female