BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARFISH 2 HEART POSITIONER

    MDR report key: 1082163 · Received July 23, 2008

    Report

    Report Number
    2135394-2008-00010
    Event Type
    Injury
    Date Received
    July 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: OTHER - DEVICE WAS DISCARDED AND NOT RETURNED TO MEDTRONIC FOR ANALYSIS. ANALYSIS - THE DEVICE WAS DISCARDED AFTER THE PROCEDURE, THEREFORE, MEDTRONIC COULD NOT PERFORM ROOT CAUSE ANALYSIS. CONCLUSION: THE DEVICE WAS DISCARDED AFTER THE PROCEDURE IN LATE 2007, AND WILL NOT BE RETURNED FOR ANALYSIS. USER ERROR CONTRIBUTED TO THIS EVENT, AS THIS DEVICE IS APPROVED FOR SINGLE USE ONLY. INFO OBTAINED REVEALED THE DEVICE WAS USED 20 OR MORE TIME AT THE TIME OF THIS INCIDENT. MEDTRONIC WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE TO DETECT SIMILAR EVENTS, SHOULD THEY OCCUR.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT ONE DAY AFTER USING THE STARFISH 2 SUCTION DEVICE IN THE CARDIO PULMONARY BYPASS PROCEDURE IN LATE 2007, A PERICARDIAL EFFUSION/BLEED WAS OBSERVED. A SECOND OPEN-HEART PROCEDURE WAS PERFORMED TO STOP THE BLEEDING. A POST-OPERATIVE ECHOCARDIOGRAM CONFIRMED THE SECOND PROCEDURE RESOLVED THE ISSUE; HOWEVER, A LEFT VENTRICULAR ANEURYSM WAS ALSO OBSERVED, WHICH WAS REPAIRED 35 DAYS AFTER THE ORIGINAL PROCEDURE. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. IT WAS NOTED THAT THE STARFISH 2 SINGLE USE DEVICE WAS USED 20 OR MORE TIMES BEFORE THIS CASE. THE INFO PERTAINING TO THIS EVENT WAS OBTAINED FROM A PRESENTATION AT THE OTHER COUNTRY'S OPEN SURGERY CONGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARFISH 2 HEART POSITIONER DWS MEDTRONIC PERFUSION SYSTEMS 29800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R