BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLP PERICARDIAL SUMP

    MDR report key: 1355037 · Received March 20, 2009

    Report

    Report Number
    2184009-2009-00006
    Event Type
    Injury
    Date Received
    March 20, 2009
    Date of Event
    January 22, 2009
    Report Date
    March 20, 2009
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K850385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: DEVICE HISTORY REVIEW COULD NOT BE PERFORMED, SINCE THE LOT NUMBER COULD NOT BE OBTAINED. RESULTS: EVALUATION 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 EVALUATION. CONCLUSION: BASED ON THE INFO PROVIDED BY THE HEALTH CARE PROFESSIONAL, THIS EVENT WAS CAUSED BY USER ERROR. 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. MEDTRONIC WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE TO DETECT SIMILAR EVENTS, SHOULD THEY OCCUR.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A MEDWATCH FDA 3500A FORM THAT DURING THE TRANSPLANT PROCEDURE, THIS PERICARDIAL SUMP WAS PLACED IN THE LEFT VENTRICULAR CAVITY OF THE DONOR HEART AND BECAME ENTANGLED IN THE LATERAL CHORDS TO THE ANTERIOR LEAFLET OF THE MITRAL VALVE. THE SUMP WAS CAREFULLY DETANGLED FROM THE CHORDS; HOWEVER, MODERATE MITRAL REGURGITATION WAS NOTED, AND AS A RESULT, THE MITRAL VALVE WAS REMOVED AND REPLACED. THE PERICARDIAL SUMP WAS NOT RETURNED FOR ANALYSIS OR AVAILABLE FOR EVALUATION.

    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 70 YR Required Intervention