BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOBLATE GEMINI

    MDR report key: 1001282 · Received February 15, 2008

    Report

    Report Number
    2135394-2008-00007
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 18, 2008
    Report Date
    January 18, 2008
    Manufacturer
    MEDTRONIC CARDIAC SURGERY TECHNOLOGIES
    Product Code
    GEI
    PMA / PMN Number
    K070311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: REASON FOR RETURN WAS CONFIRMED. VISUAL INSPECTION SHOWS ONE OF THE HOODED SHROUDS WAS MISSING AT THE END OF JAW WHEN RECEIVED. THE LOOSE SHROUD WAS NOT RETURNED WITH THIS DEVICE. FURTHER INSPECTION SHOWS THAT UV MATERIAL WAS PRESENT ON THE JAWS IN THE AREA WHERE SHROUD WAS ONCE INSTALLED. IN ADDITION, THE REMAIN ATTACHED SHROUD WAS INSPECTED. INSPECTION SHOWS THAT THIS SHROUD WAS COMPLETELY ATTACHED TO JAW END WITH NO SIGNS OF LOOSE FIT OR DETACHMENT. CONCLUSION: INVESTIGATION INTO THIS FAILURE BY MEDTRONIC AND THE SUPPLIER IDENTIFIED VARIATIONS IN THE CLEANING PROCESS OF THE SHROUDS. MANUFACTURING ENHANCEMENTS HAVE BEEN IMPLEMENTED TO CORRECT THE VARIATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT AT THE END OF THE PROCEDURE, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE SILICONE TIP CAME OFF OF THE DEVICE. THERE IS NO REPORT OF ADVERSE PATIENT AFFECT. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOBLATE GEMINI GEI MEDTRONIC CARDIAC SURGERY TECHNOLOGIES 49261 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other