BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOBLATE GEMINI

    MDR report key: 3872723 · Received June 13, 2014

    Report

    Report Number
    2184009-2014-00042
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    OCL
    PMA / PMN Number
    K080509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION CONFIRMED THAT THE HOODED SHROUD WAS MISSING. THE HOODED SHROUD WAS RETURNED WITH THE DEVICE. THE SHEATH WAS OBSERVED UNDER MAGNIFICATION, AND THERE APPEARED TO BE ADHESIVE RESIDUE ON IT. MEDTRONIC'S QUALITY ENGINEERS COULD NOT IDENTIFY THE ROOT CAUSE OF THE EVENT, AS THERE WAS EVIDENCE OF ADHESIVE ON THE SHEATH OF THE DEVICE WHERE THE SHROUD WAS ATTACHED. THESE PRODUCTS ARE 100% INSPECTED PRIOR TO RELEASE FOR DISTRIBUTION. THERE ARE NO TRENDS ASSOCIATED WITH THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION INDICATING THAT DURING ABLATION, AS THE SURGEON WAS REPOSITIONING THIS CARDIOBLATE GEMINI AND REMOVING THE CABLES FROM THE DEVICE, THE CONNECTOR ON THE TOP JAW BECAME DISCONNECTED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349599 CARDIOBLATE GEMINI SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE OCL MEDTRONIC PERFUSION SYSTEMS 49260 Q516

    Patients

    Seq Age Sex Outcome Treatment
    1