BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLP PERICARDIAL SUMP

    MDR report key: 1328663 · Received February 25, 2009

    Report

    Report Number
    2184009-2009-00004
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    January 27, 2009
    Report Date
    February 25, 2009
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K850385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD CODES: OTHER = DEVICE HISTORY REVIEW COULD NOT BE PERFORMED, SINCE THE LOT NUMBER COULD NOT BE OBTAINED. RESULT CODES: OTHER = EVAL OF THE DEVICE COULD NOT BE PERFORMED, SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ANALYSIS: ANALYSIS COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED TO MEDTRONIC FOR EVAL. CONCLUSION: BASED ON THE INFO PROVIDED BY THE CLINICIAN, THIS EVENT WAS CAUSED BY USER ERROR. AS THE INDICATIONS FOR USE (IFU) DESCRIBES, "THESE SUMPS ARE INTENDED FOR DRAINING THE PERICARDIAL SAC", INDICATIONS, PAGE 4. IN ADDITION, IT STATES THE FOLLOWING WITHIN THE CONTRAINDICATIONS SECTION ON PAGE 4: "THE PERICARDIAL SUMP (#12010, #12011) IS NOT INTENDED TO BE PLACED THROUGH A VALVE TO DRAIN A CLOSED CARDIAC CHAMBER." FURTHERMORE, THE IFU STATES: "VALVE DAMAGE MAY OCCUR IF THE PERICARDIAL SUMP (#12010, #12011) IS PASSED THROUGH VALVE LEAFLETS.", ADVERSE EFFECTS, PAGE 4. A REVIEW OF THE OUTER PACKAGING/LABEL OF THIS MODEL SUMP CONFIRMS THE CONTRAINDICATIONS AND ADVERSE EFFECTS VERBIAGE, AS STATED ABOVE, IS PROMINENTLY DISPLAYED (FRONT) WITH BOLD RED FONT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT DURING THE PROCEDURE, THIS PERICARDIAL SUMP'S TIP BECAME CAUGHT IN THE HEART BEHIND THE PAPILLARY MUSCLE, THE WEIGHTED METAL COIL HAD TO BE FISHED OUT AND RETRIEVED FROM THE PT. THERE WERE NO ADVERSE PT EFFECTS REPORTED. THE DEVICE WAS NOT RETURNED TO MEDTRONIC FOR ANALYSIS AND THE LOT NUMBER WAS UNABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DLP PERICARDIAL SUMP DWF MEDTRONIC PERFUSION SYSTEMS 12010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention