BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARBURST XLIE WITH ATTACHED TUBING 12CM

    MDR report key: 1971906 · Received January 20, 2011

    Report

    Report Number
    1056436-2011-00001
    Event Type
    Other
    Date Received
    January 20, 2011
    Date of Event
    December 22, 2010
    Report Date
    January 18, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON MEDICAL REVIEW OF THE REPORTED INCIDENT, "BUILDUP OF FLUID IN THE PERICARDIAL SAC LEADING TO CARDIAC TAMPONADE IS A PREVIOUSLY UNREPORTED AE OF RFA AND IS HIGHLY UNLIKELY TO BE CAUSED BY THE RFA PROCEDURE. IT IS MUCH MORE LIKELY THAT THE PERICARDIAL FLUID WAS PRESENT PRIOR TO INITIATION OF THE RFA PROCEDURE AND WAS THE RESULT OF THE PT'S UNDERLYING MEDICAL CONDITION."

    Description of Event or Problem · 1

    A (B)(6) OLD MALE DIAGNOSED WITH CHOLANGIOCARCINOMA WAS UNDERGOING RFA OF A LIVER LESION IN THE SUPERIOR ASPECT OF THE LIVER. PROCEDURE PLANNING AND DEVICE PLACEMENT WERE CONFIRMED, AND PT WAS TREATED TO 7CM DIAMETER ABLATION ACCORDING TO MFR PROTOCOL. SHORTLY AFTER DEPLOYMENT TO 7CM, PT EXPERIENCED AN EPISODE OF BRADYCARDIA AND A DECREASE IN BLOOD PRESSURE. DEVICE WAS REMOVED, PT WAS STABILIZED, AND CT SCAN REVEALED PERICARDIAL FLUID. AS A PRECAUTION, THE PT WAS TRANSPORTED TO THE LOCAL HOSPITAL FOR EVAL. THE RFA TREATMENT APPEARED TO PROGRESS NORMALLY, AND THE DEVICE APPEARED FULLY INTACT AND FUNCTIONALLY UPON REMOVAL. DEVICE WAS SAVED FOR INSPECTION. UPON ARRIVAL TO THE HOSPITAL, THE PT WAS FOUND TO HAVE PERICARDIAL FLUID CAUSING A TAMPENADE (TAMPONADE). SURGERY WAS PERFORMED TO CREATE A PERICARDIAL WINDOW TO RELIEVE THE FLUID PRESSURE. PT WAS STABLE POST-SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARBURST XLIE WITH ATTACHED TUBING 12CM RFA PROBE GEI ANGIODYNAMICS NA 519367

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other