BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNBALLOON NON-OCCLUSION MODELING CATHETER

    MDR report key: 2912848 · Received December 3, 2012

    Report

    Report Number
    1220948-2012-00021
    Event Type
    Other
    Date Received
    December 3, 2012
    Date of Event
    October 19, 2012
    Report Date
    November 5, 2012
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K110891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE COMPLAINT DEVICE FOR EVAL AND WERE NOT ABLE TO VERIFY THE FAILURE MODE. LOT HISTORY RECORDS REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT EITHER DURING THE MFG OR PACKAGING PROCESS. ALL MFG AND QC STEPS WERE COMPLETED IN ACCORDANCE TO MFG INSTRUCTIONS. THEREFORE, THE ROOT CAUSE OF THE INCIDENT IS INCONCLUSIVE. PLEASE NOTE THAT THE IFU WARNS TO PAY PARTICULAR ATTENTION WHEN USING THE UNBALLOON DEVICE WITH ENDOGRAFTS CONTAINING ENDOSKELETONS. 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

    WHILE INSERTING THE UNBALLOON THROUGH AN ENDOLOGIX 18F INTRODUCER CATHETER, RESISTANCE WAS MET. DR (B)(6) CONTINUED TO TRY TO ADVANCE UNBALLOON WITH RESISTANCE, FINALLY THE RESISTANCE HALTED AND THE UNBALLOON FORCEFULLY ENTERED THE ENDOGRAFT. THE UNBALLOON GOT CAUGHT ON THE INTERNAL FIXATION OF THE GRAFT AND MIGRATED THE ENTIRE GRAFT UP OVER THE RENAL ARTERIES. THE UNBALLOON WAS IMMEDIATELY REMOVED AND A CODA BALLOON WAS INSERTED TO SUCCESSFULLY PULL THE GRAFT DOWN. NO PT INJURY HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNBALLOON NON-OCCLUSION MODELING CATHETER UNBALLOON DQY LEMAITRE VASCULAR 4300-02 UMC1066

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R