BEUDAMED
    FDA Adverse Event Other Summary report: N

    MOLLRING CUTTER

    MDR report key: 998518 · Received February 8, 2008

    Report

    Report Number
    1220948-2008-00001
    Event Type
    Other
    Date Received
    February 8, 2008
    Date of Event
    December 24, 2008
    Report Date
    January 21, 2008
    Manufacturer
    VASCULAR ARCHITECHS
    Product Code
    DWX
    PMA / PMN Number
    K950813
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A PROCEDURE INVOLVING A MOLLRING CUTTER, THE TIP OR RING BROKE AND BECAME LODGED WITHIN THE SUPERFICIAL FEMORAL ARTERY. THE RING WAS GRASPED WITH ANOTHER MOLLRING DEVICE AND ADVANCED 8CM TO ALLOW A FOGARTY BALLOON TO COMPLETELY REMOVE THE RING COMPLETELY FROM THE SUPERFICIAL FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT. THE DEVICE WAS EVALUATED ON 1/2/2008. FROM OUR EVALUATION WE WERE ABLE TO CONFIRM THE REPORTED COMPLAINT. WHEN THE DEVICE WAS RETURNED, IT WAS CONFIRMED THAT THE PROXIMAL RING WAS DETACHED FROM THE DEVICE. THE DEVICE ARM WAS VERY DIFFICULT TO EXTEND. THE ROOT CAUSE OF THE DEVICE MALFUNCTION REMAINS INCONCLUSIVE AT THIS TIME. VASCULAR ARCHITECHS WAS ACQUIRED BY LEMAITRE VASCULAR INC. IN SEPTEMBER 2007. FOR THIS REASON, THIS REPORT IS BEING SUBMITTED BY LEMAITRE VASCULAR.

    Description of Event or Problem · 1

    THE MOLLRING CUTTER DEVICE WAS ADVANCED DOWN THE SUPERFICIAL FEMORAL ARTERY. UPON TRANSECTION, THE MOLLRING CUTTER TIP OR RING BROKE AND BECAME LOOSE WITHIN THE SUPERFICIAL FEMORAL ARTERY. ANOTHER MOLLRING DEVICE WAS USED TO GRASP THE TIP AND MOVED THE TIP FOR APPROXIMATELY 8CM. A FOGARTY CATHETER BALLOON WAS THEN USED TO REMOVE THE TIP COMPLETELY FROM THE SUPERFICIAL FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOLLRING CUTTER MOLLRING CUTTER DWX VASCULAR ARCHITECHS MRC4406 050107

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention