BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANT STENT GRAFT BALLOON CATHETER

    MDR report key: 935380 · Received April 12, 2007

    Report

    Report Number
    2953200-2007-00160
    Event Type
    Malfunction
    Date Received
    April 12, 2007
    Date of Event
    March 16, 2007
    Report Date
    March 16, 2007
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    DQY
    PMA / PMN Number
    k050038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. A RELIANT STENT GRAFT BALLOON CATHETER WAS USED TO IRON OUT THE STENT GRAFT BELOW THE FLOW DIVIDER. THE RELIANT STENT GRAFT BALLOON CATHETER WAS PLACED COMPLETELY WITHIN THE STENT GRAFT. A 30CC SYRINGE WITH 75% SALINE AND 25% CONTRAST WAS USED TO INFLATE THE BALLOON. IT WAS REPORTED THAT AFTER THE SECOND INFLATION THE BALLOON BURST. IT WAS SUCCESSFULLY REMOVED FROM PATIENT. THE PHYSICIAN USED ANOTHER RELIANT STENT GRAFT BALLOON CATHETER AND SUCCESSFULLY COMPLETED THE CASE. THE RELIANT STENT GRAFT BALLOON CATHETER WAS DISCARDED BY THE USER FACILITY. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANT STENT GRAFT BALLOON CATHETER DQY DQY MEDTRONIC VASCULAR NA 0000382823

    Patients

    Seq Age Sex Outcome Treatment
    1 YR