BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 2121746 · Received May 20, 2011

    Report

    Report Number
    2951250-2011-00032
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 21, 2011
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    A PHYSICIAN ENCOUNTERED A PROBLEM DURING PLACEMENT OF ESSURE MICRO-INSERTS IN HIS PT; 1 ESSURE HANDLE DID NOT DETACH FROM THE MICRO-INSERT. UPON ENCOUNTERING PLACEMENT DIFFICULTY, THE PHYSICIAN ATTEMPTED TO PULL THE CATHETER AND DEVICE OUT OF THE PT'S OSTIUM, BUT NEITHER WOULD RELEASE. THE PHYSICIAN UTILIZED WIRE CUTTERS TO DETACH PURPLE HANDLE FROM CATHETER IN ORDER TO REMOVE HYSTEROSCOPE FROM PT AND THEN WALKED THE PT TO THE OPERATING ROOM FOR EMERGENCY SURGERY. THE PHYSICIAN REMOVED THE CATHETER AND DELIVERY WIRE FROM DEVICE TRANS-VAGINALLY/TRANS-CERVICALLY, THEN VISUALIZED PROPERLY PLACED MICRO-INSERT IN THE RIGHT OSTIUM. THE PHYSICIAN REPORTED 'NO INJURY' TO PT AND NO FURTHER ACTION TAKEN OTHER THAN THAT DESCRIBED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 823468

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention