BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URCHIN HEART POSITIONER

    MDR report key: 588909 · Received March 30, 2005

    Report

    Report Number
    2135394-2005-00004
    Event Type
    Malfunction
    Date Received
    March 30, 2005
    Date of Event
    March 1, 2005
    Report Date
    March 1, 2005
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION REVIEWED INDICATES AN OFF-PUMP CASE WAS PERFORMED FOR A PT WITH FRIABLE CARDIAC TISSUE. THE REPORT STATES THE PRODUCT WAS REMOVED AND A TEAR WAS NOTED AT THE APEX OF THE HEART REQUIRING SUTURE PLACEMENT. THE SURGEON STATES THE CARDIAC TISSUE WAS FRIABLE AT THE APEX OF THE HEART. THE PT HAS SHOWN NO ADVERSE REACTION AND NO SUBSEQUENT COMPLICATION WAS REPORTED FOLLOWING CASE COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URCHIN HEART POSITIONER HEART POSITIONER DWS MEDTRONIC PERFUSION SYSTEMS 29700 2004120326

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention