BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBICATH STEERABLE SHEATH

    MDR report key: 2802398 · Received October 19, 2012

    Report

    Report Number
    2183787-2012-00081
    Event Type
    Injury
    Date Received
    October 19, 2012
    Report Date
    October 16, 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 DURING A LEFT ATRIAL FLUTTER ABLATION A SMALL PERICARDIAL EFFUSION WAS NOTICED AT THE START OF THE PROCEDURE USING INTRACARDIAC ULTRASOUND. BASELINE BP WAS NOTED TO BE 90/60. DOUBLE TRANSEPTAL WAS PERFORMED AND THE PULMONARY VEINS WERE ISOLATED. WHILE PERFORMING A LEFT ATRIAL ISTHMUS LINE THE PT'S BLOOD PRESSURE WAS NOTED TO BE DOWN TO 70/40. INTRACARDIAC ULTRASOUND WAS USED TO IDENTIFY A LARGE PERICARDIAL EFFUSION AS THICK AS 1.5 CM. PERICARDIOCENTESIS WAS PERFORMED AND APPROX 760 CC OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PT WAS STABILIZED WITH A BLOOD PRESSURE OF 80/50 IN THE RECOVERY ROOM AT THE TIME OF THE CALL. THE PT WILL BE ADMITTED FOR OBSERVATION. THE FACILITY INDICATES THAT THE PREEXISTING EFFUSION COMBINED WITH ANTICOAGULATION FOR THE PROCEDURE MAY HAVE CONTRIBUTED TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBICATH STEERABLE SHEATH STEERABLE SHEATH DYB GREATBATCH MEDICAL 1000182-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other