BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 1163226 · Received September 15, 2008

    Report

    Report Number
    2951250-2008-00022
    Event Type
    Other
    Date Received
    September 15, 2008
    Date of Event
    July 3, 2008
    Report Date
    February 14, 2017
    Manufacturer
    CONCEPTUS, INC.
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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

    PHYSICIAN REPORTED DIFFICULT DETACHING MICRO-INSERT FROM DELIVERY SYS DURING PROCEDURE. MICRO-INSERT WAS SUCCESSFULLY DEPLOYED BUT FAILED TO DETACH AFTER TROUBLESHOOTING STEPS ATTEMPTED. PHYSICIAN CUT THE DELIVERY SYS AT THE MICRO INSERT, LEAVING SOME PIECES OF THE DELIVERY SYS ATTACHED TO THE MICRO INSERT. MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE REMAINING PIECES OF DELIVERY CATHETER AS IT IS NOT INTENDED TO BE A PERMANENT IMPLANT. PT WAS TRANSFERRED TO OR. PHYSICIAN PERFORMED A SECOND HYSTEROSCOPY AND REMOVED ALL REMAINING PIECES OF GREEN DELIVERY CATHETER. THE MICRO-INSERT SEEMED TO BE PROPERLY LOCATED SO IT WAS LEFT IN PLACE. DELIVERY SYS WAS RETURNED TO CONCEPTUS. EVAL OF DEVICE SHOWED THAT ALL SYS COMPONENTS WITHIN SPEC, THUS THE CAUSE OF THE DETACHMENT DIFFICULTIES COULD NOT BE CONFIRMED. DETACHMENT DIFFICULTIES MAY BE EXACERBATED BY TUBAL TORTUOSITY, FIBER INTERFERENCE OR COMPONENT DEFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE INSERT, TUBAL OCCLUSION HHS CONCEPTUS, INC. ESS305 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other