BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI GRANDSLAM PTCA GUIDE WIRE

    MDR report key: 1972082 · Received January 27, 2011

    Report

    Report Number
    3003775027-2011-00001
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    November 3, 2010
    Report Date
    January 3, 2011
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K031277
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. FROM THE OBTAINED INFORMATION, IT IS PRESUMED THAT THE TIP OF THE GUIDE WIRE INADVERTENTLY TOUCHED THE ATHERECTOMY DEVICE AND THE TIP OF THE GUIDE WIRE WAS SEPARATED. HOWEVER, WE COULD NOT CONFIRM THE DETAILS SINCE THE GUIDE WIRE IN QUESTION WAS NOT RETURNED FOR ANALYSIS. THE WARNING SECTION OF THE IFU DESCRIBES SEPARATION OR BREAKAGE OF GUIDE WIRE AS ONE OF THE POSSIBLE COMPLICATIONS AND ADVERSE EVENTS ASSOCIATED WITH USE OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTIVE PROCEDURE WAS TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), USING AN ARTHRECTOMY DEVICE WITH AN EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM OVER AN ASAHI GRANDSLAM GUIDE WIRE. THE GRANDSLAM GUIDE WIRE WAS INADVERTENTLY SEVERED ON SECOND PASS DURING THE ATHERECTOMY. THE GUIDE WIRE WAS REMOVED WITH A SNARE DEVICE EXCEPT FOR THE VERY TIP (3 CM), WHICH REMAINED IN A VERY SMALL INSIGNIFICANT BRANCH OF THE RIGHT SFA. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT WAS DISCHARGED WITH NO SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI GRANDSLAM PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EMBOSHIELD NAV6