BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOLLRING CUTTER TRANSECTION DEVICE

    MDR report key: 2104796 · Received May 26, 2011

    Report

    Report Number
    1220948-2011-00004
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Report Date
    April 15, 2011
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    DWX
    PMA / PMN Number
    K950813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE DEVICE FOR EVALUATION AND WERE ABLE TO VERIFY THE FAILURE. THE TOP (PROXIMAL) RING WELDING EVALUATION DID NOT REVEAL ANY PROBLEMS DURING THE MANUFACTURING PROCESS - WELD WAS DONE CORRECTLY. THE ROOT CAUSE OF THE FAILURE IS INCONCLUSIVE. IT IS POSSIBLE THE EXCESSIVE FORCE AND/OR CALCIFIED VESSEL CONTRIBUTED TO THE FAILURE. PLEASE NOTE THAT WE DO NOT RECOMMEND THE USE OF MOLLRING CUTTER DEVICES FOR CUTTING CALCIFIED MATERIAL SINCE IT MAY DAMAGE THE DEVICE (PLEASE REFERENCE LEMAITRE VASCULAR, INC. IFU PRECAUTION SECTION FOR MORE DETAILS - SEE ATTACHMENT). PLEASE NOTE THAT THE PATIENT IS FINE AND THE CASE WAS DONE SUCCESSFULLY.

    Description of Event or Problem · 1

    THE MOLLRING DEVICE WAS USED FOR ENDARTERECTOMY PROCEDURE. THE DEVICE WAS PASSED TO THE DISTAL PORTION OF THE SFA, WHERE IT WAS INTENDED TO CUT THE PLAQUE. THE PLAQUE WAS CALCIFIED DISTALLY. WHEN DR (B)(6) PULLED THE WHITE HANDLE AWAY FROM THE BLUE TO ENGAGE THE CUTTER, THE TOP CUTTING RING DISENGAGED ITSELF PERPENDICULAR TO THE BOTTOM BLADE UNDER FLUORO. IT WAS ASSUMED THAT THERE WAS AN ISSUE WITH THE CUTTER. THE PHYSICIAN WAS UNABLE TO GET THE CUTTING RINGS TO GO BACK TOGETHER, BUT HE WAS ABLE TO REMOVE THE CORE. UPON INSPECTION, THE TOP RING WAS CAUGHT AROUND THE CORE. WHEN THE CORE WAS REMOVED FROM THE RING, IT WAS FOUND THAT THE TOP RING HAD ACTUALLY BROKEN AT THE WELD AWAY FROM ITS SHAFT AND HAD GOTTEN STUCK IN THE CORE. PATIENT IS FINE AND THE CASE WAS DONE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOLLRING CUTTER TRANSECTION DEVICE MOLLRING CUTTER DWX LEMAITRE VASCULAR 4200-42 MOL1055

    Patients

    Seq Age Sex Outcome Treatment
    1