BEUDAMED
    FDA Adverse Event Death Summary report: N

    PT GRAPHIX

    MDR report key: 2052247 · Received March 24, 2011

    Report

    Report Number
    2052247
    Event Type
    Death
    Date Received
    March 24, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BROUGHT IN AS AN OUTPATIENT TO HAVE AN ATTEMPTED PTCA/STENT PLACEMENT IN A CHRONIC, TOTALLY OCCLUDED CIRCUMFLEX ARTERY THAT HAD TWO STENTS PLACED DURING PREVIOUS YEARS. DURING THE COURSE OF THE PROCEDURE, A CORONARY GUIDEWIRE WAS BEING USED TO GO PAST THE BLOCKAGE AND TWO ALREADY EXISTING CROSSED STENTS.THE END OF THE GUIDE WIRE BROKE OFF INSIDE THE CIRCUMFLEX ARTERY AND MIGRATED TO THE DISTAL END OF THE LAD. STAFF BELIEVES THAT THE GUIDEWIRE BECAME ENTANGLED WITH THE TWO ALREADY IN PLACE STENTS AND THE TIP BROKE OFF. AN ATTEMPT WAS MADE TO RETRIEVE THE BROKEN PIECE OF THE GUIDEWIRE WITH A MICRO-SNARE. ONE UNSUCCESSFUL ATTEMPT WAS MADE AT WHICH TIME THE MICRO-SNARE AND CATHETER WERE REMOVED FROM THE LAD. SUBSEQUENT ANGIOGRAM SHOWED SLOWER FLOW IN THE LAD AND THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. A GUIDEWIRE WAS PLACED DOWN THE LAD AND ATTEMPTS WERE MADE TO OPEN THE PARTIALLY OCCLUDED LAD. THE CIRCUMFLEX WAS ALSO NOTED TO BE SHUTTING DOWN. THE PATIENT CONTINUED TO BECOME MORE UNSTABLE AND CPR WAS INITIATED TWO SEPARATE TIMES. AFTER APPROXIMATELY 20 MINUTES OF RESUSCITATION EFFORTS, THE CODE WAS CALLED AND THE PATIENT WAS PRONOUNCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT GRAPHIX PT GRAPHIX INTERMEDIATE GUIDE WIRE DQX BOSTON SCIENTIFIC CORPORATION 14914-01J2 13745988

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death