BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM ADVANTA V12

    MDR report key: 4012502 · Received August 12, 2014

    Report

    Report Number
    1219977-2014-00234
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    JCT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING AN INTERNAL ILIAC PSEUDOANEURYSM AND ACCESS WAS GAINED THROUGH THE FEMORAL ARTERY. THE STENT WAS INSERTED AND IT WAS TIGHT PASSING UP AND OVER THE BIFURCATION; HOWEVER, STENT LANDED IN INTENDED POSITON. THE BALLOON WAS INFLATED AND FORCE WAS USED TO REMOVE THE BALLOON FROM THE SHEATH. WHILE PULLING OVER BIFURCATION THE PLASTIC CATHETER HUB BROKE OFF THE CATHETER SHAFT. THE CATHETER WAS REMOVED SLOWLY: THE PHYSICIAN HAD TO CUT HALF THE LENGTH OF CATHETER OFF AND REMOVE IT, THEN CONTINUED TO PULL THE REST OF THE SHAFT OUT AND THE BALLOON WAS REMOVED THROUGH THE SHEATH. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478873 ATRIUM ADVANTA V12 PROSTHESIS, RENAL, ILIAC, EXPANDABLE JCT ATRIUM MEDICAL CORP. 85360 208313

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention