BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOBLATE GEMINI

    MDR report key: 1962534 · Received January 6, 2011

    Report

    Report Number
    2135394-2011-00001
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    OCL
    PMA / PMN Number
    K080509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: METHOD: DEVICE HISTORY REVIEW IS PENDING. RESULTS: DEVICE HISTORY REVIEW IS PENDING. NO PRODUCT HAS BEEN RETURNED FOR ANALYSIS. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT HAS BEEN RETURNED FOR ANALYSIS AND THE DEVICE HISTORY REVIEW HAS BEEN REQUESTED. CONCLUSION: DUE TO THE LIMITED INFORMATION AT THIS TIME, THE CAUSE FOR THIS EVENT COULD NOT BE DETERMINED; HOWEVER, THE PULMONARY VEINS (PV) ARE VERY DELICATE STRUCTURES AND THE CLAMP IS OBVIOUSLY VERY RIGID. INADVERTENT TORQUE OR ROUGH HANDLING OF THE DEVICE IS TRANSMITTED DIRECTLY TO THE TISSUE, WHICH COULD RESULT IN TRAUMA OR TEARING OF THE TISSUE. IN ADDITION, IT WAS NOT MENTIONED WHETHER OR NOT THE DEVICE WAS USED TO MAKE OTHER LESIONS PRIOR TO THE PV'S. PERHAPS IT WAS SET ASIDE FOR A SHORT TIME ALLOWING BLOOD TO DRY IN AND CLOG THE POROUS POLYMER BETWEEN THE JAWS. A LACK OF SALINE FLOWING FROM THE JAWS CAN CAUSE EXCESSIVE DAMAGE/PERFORATION TO THE TISSUE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS GEMINI S DEVICE, A TEAR OF THE PULMONARY VEINS OCCURRED, REQUIRING SURGICAL REPAIR. IT WAS REPORTED THAT THIS OCCURRED WHEN THE DEVICE WAS "PULLED" AROUND THE PULMONARY VEINS. THERE WAS NO FURTHER CONSEQUENCE TO THE PATIENT. THE PRODUCT WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOBLATE GEMINI OCL MEDTRONIC PERFUSION SYSTEMS 49260 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| R