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

Model Number ESS305

Device Problem Device Or Device Fragments Location Unknown (2590)

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

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a gynecologist/obstetrician in united states on 14-mar-2015 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted.Additional information was received on 16-mar-2015.Physician (who was not the inserting physician) reported that the patient sent a film shot of her hysterosalpingogram (hsg).He forwarded the film and it appears that there are 5 implants in the tube and one could have been the delivery catheter.Follow-up information received on 23-mar-2015 and ptc investigation result received on 24-mar-2015 physician stated that he did not have information regarding any specifics of the patient.(b)(4).Final assessment: 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 to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.No new failure mode has been identified.Medical assessment: this product technical complaint was initiated due to a reported product quality issue as well as a usability issue.No medical events were reported at this time.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 further investigation therefore the complaint could not be evaluated in greater detail.The technical assessment concluded unconfirmed quality defect.As no medical events were reported, an assessment of a relationship is not applicable.Company causality comment: this medically confirmed, spontaneous case report; refers to a female patient who had essure (fallopian tube occlusion insert) inserted and at hysterosalpingogram (hsg) it appeared 5 implants were in the tube; reporter suspected one could have been the delivery catheter.These events, regarded as device misuse and suspicion of device breakage, were considered non-serious.Device breakage is unlisted according to essure's reference safety information, while the other event is listed.Single cases of essure breakage have been reported, mainly during difficult insertions/removals.In this particular case, although the exact date and mechanism of the reported device breakage is not known; a causal relationship with the suspect insert cannot be excluded.The remaining event was considered as unrelated to essure due to its nature (misuse).This case was regarded as an other reportable incident as although the suspected device breakage did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect (no batch number was provided).Medical ptc assessment considered that, based on the available information, there is no reason to suspect quality defect of the product.No further information is expected.

Manufacturer Narrative

Data correction: the product 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: 4679211
• MDR Text Key: 5642299
• Report Number: 2951250-2015-00250
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Paramedic
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

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 Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2015
• Initial Date FDA Received: 04/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• 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