BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNBALLOON NON-OCCLUSIVE MODELING CATHETER

    MDR report key: 2860292 · Received November 14, 2012

    Report

    Report Number
    1220948-2012-00018
    Event Type
    Other
    Date Received
    November 14, 2012
    Report Date
    October 26, 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 25 MM AND THE SIZE OF THE MAIN BODY WAS 22 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

    THE UNBALLOON WAS USED TO MODEL THE ENDOLOGIX GRAFT. THE 25 MM CUFF WAS DEPLOYED. THE ANATOMY WAS STRAIGHT WITHOUT MUCH TORTUOSITY. THE SURGEON DEPLOYED THE UNBALLOON (DEVICE) IN THE PROXIMAL CUFF. HE WANTED TO MOVE THE DEVICE PROXIMAL, BUT WHEN HE TRIED TO RESHEATH THE DEVICE, IT WOULD NOT RESHEATH AS HIS WAS CAUGHT ON A STENT STRUT. HIS OPINION WAS THAT WHEN THE SHEATH HUNG ON THE CUFF THE DEVICE PUSHED THE CUFF PROXIMALLY. THE CUFF THEN BECAME HUNG UP ON THE UNBALLOON CAGE. THE PHYSICIAN WAS ABLE TO MOVE THE WHOLE DEVICE DISTALLY AND SHEATH IT. THE CUFF MIGRATED NORTH ENOUGH TO COVER THE LEFT RENAL 5 MM. THE SURGEON DEPLOYED A CODA BALLOON MID-CUFF AND OVER INFLATED IT TO "GRAB" THE CUFF. HE WAS ABLE TO MOVE THE CUFF SOUTH ABOUT 4 MM. THERE WAS ABOUT 1 MM OF GRAFT BLOCKING THE PTS LEFT RENAL. THE SURGEON AND THE ENDOLOGIX REP FELT THAT IT WAS JUST METAL IN FRONT OF THE RENAL WITH NO GRAFT MATERIAL BLOCKING THE RENAL. 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 UMC1050

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R