BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBICATH STEERABLE SHEATH

    MDR report key: 2802418 · Received October 19, 2012

    Report

    Report Number
    2183787-2012-00083
    Event Type
    Injury
    Date Received
    October 19, 2012
    Report Date
    October 18, 2012
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K101784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ON A LEFT ATRIAL FLUTTER CASE, THE PT'S BLOOD PRESSURE DROPPED AND A LARGE PERICARDIAL EFFUSION WAS CONFIRMED WITH ECHO ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED AND AN UNK LARGE AMOUNT OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PT WAS STABLE AND ADMITTED IN THE ICU FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBICATH STEERABLE SHEATH STEERABLE SHEATH DYB GREATBATCH MEDICAL 1000182-002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other