BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III

    MDR report key: 2513030 · Received March 16, 2012

    Report

    Report Number
    2513030
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    February 1, 2012
    Report Date
    March 16, 2012
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    CIRCULATOR ATTEMPTED TO OPEN OUTSIDE PACKAGING TO DELIVER TRAY WITH THE INSTRUMENT TO THE STERILE FIELD. IN DOING SO, THE PEEL-AWAY CORNER OF OUTER WRAP EITHER BENT BACK OR OTHERWISE MADE RN THINK THAT THE INNER PACKAGE HAD BEEN CONTAMINATED. THE INNER PACKAGE HAS SEMI-RIGID TRAY WITH A COVER (BOTH PLASTIC) THAT IS IN TURN COVERED WITH A PEEL-BACK PLASTIC-LIKE COVERING LAYER. RN WOULD NORMALLY NEVER REMOVE THIS PEEL-BACK COVERING BUT WOULD HAND TRAY OVER USING OUTER PAPER PACKAGING. BECAUSE THIS PRODUCT COSTS $6,000, THE RN ATTEMPTED TO PEEL OFF THE INSIDE COVER SO SHE COULD HAND OVER THE TRAY IN OPEN CONDITION. THE CATHETER IN THE TRAY FLIPPED OUT OF THE PACKAGING AND WAS CONTAMINATED. THEREFORE THE PRODUCT WAS UNUSABLE. PHOTOS CAN BE SUPPLIED TO DEMONSTRATE THE CONDITIONS.======================MANUFACTURER RESPONSE FOR LASER CATHETER TO CREATE NEW CARDIAC COLLATERAL CIRCULATION (TMR), SOLOGRIP III 43% (PER SITE REPORTER).======================"HAVE NEVER SEEN THIS HAPPEN BEFORE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLOGRIP III LASER, TRANSMYOCARDIAL REVASCULARIZATION MNO CARDIOGENESIS CORPORATION 705-37020 TA-03797

    Patients

    Seq Age Sex Outcome Treatment
    1 *