BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO EXPANDABLE LEMAITRE VALVULOTOME

    MDR report key: 6206545 · Received December 27, 2016

    Report

    Report Number
    1220948-2016-00025
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    November 27, 2016
    Report Date
    December 21, 2016
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    UDI-DI
    00080663106653
    PMA / PMN Number
    K140042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND THEREFORE NOT AVAILABLE FOR EVALUATION, HOWEVER A PICTURE OF THE DEVICE WAS SUBMITTED WITH THE COMPLAINT. WHILE WE CANNOT DETERMINE CONCLUSIVELY THE CAUSE OF THE REPORTED FAILURE, THIS ISSUE IS MOST CONSISTENT WITH A FAILURE OF THE VALVULOTOME TO PERFORM AS EXPECTED. DEVICE DISCARDED BY PHYSICIAN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A NON-REVERSED BYPASS THE PHYSICIAN FELT RESISTANCE WHEN PULLING THE CATHETER. HE TRIED TO CLOSE THE BLADES INTO THE SHEATH BUT COULD NOT. HE PULLED THE CATHETER AND CUT THE DISTAL END OF THE VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856717 HYDRO EXPANDABLE LEMAITRE VALVULOTOME VALVULOTOME, EXTERNAL VEIN STRIPPER MGZ LEMAITRE VASCULAR, INC. N/A ELVH1113V 00080663106653

    Patients

    Seq Age Sex Outcome Treatment
    1 Other