BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNBALLOON NON-OCCLUSIVE MODELING CATHETER

    MDR report key: 2860300 · Received November 14, 2012

    Report

    Report Number
    1220948-2012-00017
    Event Type
    Other
    Date Received
    November 14, 2012
    Report Date
    October 17, 2012
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K110891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION AND WERE ABLE TO CONFIRM THE FAILURE. THE TIP OF THE SHEATH WAS DAMAGED. IT LOOKS LIKE THE TIP WAS CAUGHT ON THE ENDOSKELETON OF THE GRAFT/CUFF AND WAS STRETCHED OUT. THE SIZE OF THE CUFF WAS 28 MM AND THE SIZE OF THE MAIN BODY WAS 25 MM. THIS MEANS THAT THE VESSELS SIZE WAS LESS THAN 25 MM DUE TO GRAFTS OVER SIZING REQUIREMENTS. THE IFU CONTRAINDICATES USE OF THE UNBALLOON DEVICES FOR TREATMENT OF VESSELS WITH DIAMETERS LESS THAN 25 MM. LOT HISTORY RECORDS REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT EITHER DURING THE MANUFACTURING OR PACKAGING PROCESSES. ALL MANUFACTURING AND QC STEPS WERE COMPLETED IN ACCORDANCE TO MANUFACTURING INSTRUCTIONS. THEREFORE, THE ROOT CAUSE OF THE INCIDENT IS THE PHYSICIAN DID NOT FOLLOW IFU. HOWEVER, LEMAITRE VASCULAR INC. HAS INITIATED THE CORRECTIVE AND PREVENTIVE ACTION TO RESEARCH THIS ISSUE IN MORE DETAILS (PLEASE REFERENCE LEMAITRE CAPA (B)(4) FOR MORE DETAILS). PLEASE NOTE THAT NO PT INJURY HAPPENED DURING THIS INCIDENT.

    Description of Event or Problem · 1

    A TIP OF THE DEVICE WAS CAUGHT ON ENDOSKELETON IN CUFF WHEN ADVANCING THE DEVICE INSIDE THE VESSEL. IT CAUSED THE CUFF MIGRATION. NO PT INJURY HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNBALLOON NON-OCCLUSIVE MODELING CATHETER UNBALLOON DQY LEMAITRE VASCULAR 4300-02 UMC1064A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R