BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URCHIN HEART POSITIONER

    MDR report key: 1582011 · Received January 14, 2010

    Report

    Report Number
    2135394-2010-00001
    Event Type
    Injury
    Date Received
    January 14, 2010
    Date of Event
    December 14, 2009
    Report Date
    December 16, 2009
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS = DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. ANALYSIS: THIS PRODUCT WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. THE INSTRUCTIONS FOR USE STATE, "DO NOT EXCEED (-)250 MM HG OF SUCTION." CONCLUSION: NO PRODUCT WAS RETURNED FOR ANALYSIS; THEREFORE, THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED BASED ON CONCRETE ANALYSIS. HOWEVER, BASED ON THE INFORMATION PROVIDED, IT IS LIKELY THAT USER ERROR CAUSED THIS EVENT, WHEN THE SUCTION WAS INCREASED TO 600 MM HG INADVERTENTLY, RESULTING IN DAMAGE TO THE PATIENT'S VENTRICLE.

    Description of Event or Problem · 1

    MEDTRONIC CARDIOVASCULAR RECEIVED INFORMATION THAT DURING A CASE, THE SUCTION ON THIS URCHIN DEVICE WAS INADVERTENTLY INCREASED TO 600MMHG (WAY OVER THE LABELED 250MMHG). THIS RESULTED IN A TEAR IN THE PATIENT'S VENTRICLE. THE SURGEON SUTURED THE HOLE IN THE VENTRICLE, AND THE MEDTRONIC SALES REPRESENTATIVE REPORTED THAT THE PATIENT WAS DOING FINE. THE PRODUCT WAS DISCARDED AND WOULD NOT BE RETURNED TO MEDTRONIC FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URCHIN HEART POSITIONER DWS MEDTRONIC PERFUSION SYSTEMS 29700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R