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U.S. Department of Health and Human Services

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

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BAYER PHARMA AG ESSURE INSERT, TUBAL OCCLUSION Back to Search Results
Catalog Number ESS305
Event Type  Injury  
Event Description

This spontaneous case was reported by an other health professional and describes the occurrence of device deployment issue ("during placement of the essure material in the patient's right uterine tube, the catheter remained stuck in the tube and the insert became unwound when i attempted to withdraw the catheter") and complication of device insertion ("during placement of the essure material in the patient's right uterine tube, the catheter remained stuck in the tube and the insert became unwound when i attempted to withdraw the catheter") in a female patient who had essure (batch no. 50512918) inserted for female sterilization. On (b)(6) 2012, the patient had essure inserted. On the same day, the patient experienced device deployment issue and complication of device insertion. At the time of the report, the device deployment issue and complication of device insertion outcome was unknown. The reporter provided no causality assessment for complication of device insertion and device deployment issue with essure. The reporter commented: the material had to be removed by pulling on it, which could have damaged the tube. What was stuck in the tube included the green delivery catheter that sheaths the insert. After removal, i used another package to place another insert in order to ensure bilateral tubal sterilisation. Company causality comment: this spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and during placement of the essure material in the patient's right uterine tube, the catheter remained stuck in the tube and the insert became unwound when i attempted to withdraw the catheter. This event, interpreted as device deployment issue, is anticipated in the reference safety information for essure. In the present case the event occurred during essure insertion procedure, therefore causality with essure cannot be excluded. Although there was no reported death or serious health deterioration, this might have occurred under less fortunate circumstances and therefore case was regarded as a reportable incident. A product technical analysis and further information are expected.

 
Manufacturer Narrative

On march 3, 2017, bayer received a cluster of essure complaint reports originating from the ansm, health authority of (b)(4), device vigilance database via legal proceedings. Following receipt, bayer consulted ansm in order to obtain the relevant casereference number information. On march 24, 2017, ansm provided the available corresponding case reference numbers to bayer. Upon receipt of this information bayer evaluated and processed the cluster of essure reports within the global safety database by april 12, 2017.

 
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Brand NameESSURE
Type of DeviceINSERT, TUBAL OCCLUSION
Manufacturer (Section D)
BAYER PHARMA AG
müllerstr. 178
berlin, 13353
GM  13353
Manufacturer (Section G)
BAYER PHARMA AG
müllerstr. 178
berlin, 13353
GM  13353
Manufacturer Contact
k. shaw lamberson
100 bayer blvd. p.o. box 915
whippany , NJ 07981-0915
MDR Report Key6533560
Report Number2951250-2017-01824
Device Sequence Number1
Product CodeHHS
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 11/15/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/01/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberESS305
Device LOT Number50512918
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/20/2017
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

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