BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE

    MDR report key: 2031706 · Received March 22, 2011

    Report

    Report Number
    2939520-2011-00013
    Event Type
    Death
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K100930
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER - COMPLAINT AND MANUFACTURING DOCUMENTS WERE REVIEWED. (B)(4). THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED WHEN THE ROOM WAS CLEANED, THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. THE PHYSICIAN BELIEVES THAT THE CAUSE OF DEATH WAS "AN ACUTE CLOSURE OF THE LAD" AND WAS OFFICIALLY DOCUMENTED AS CARDIAC ARREST AND DEATH. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A FEMALE PATIENT WITH BREAST CANCER WAS SCHEDULED FOR CATHETERIZATION AS SURGICAL CLEARANCE FOR MASTECTOMY. THE PHYSICIAN WANTED TO USE (B)(4) TO DETERMINE SIGNIFICANCE OF LESION. THE WIRE WAS INSERTED INTO THE LEFT MAIN ARTERY AND NORMALIZED. THE WIRE WAS THEN INSERTED PAST LESION IN QUESTION, GRADIENT ASSESSED WITHOUT ADENOSINE AND THE READING WAS .85. ADENOSINE WAS THEN ADMINISTERED AND ANOTHER (B)(4) READING WAS OBTAINED WHICH WAS .78. SINCE THE PROCEDURE WAS FOR THE SURGICAL CLEARANCE, THE PHYSICIAN DID NOT WANT TO PLACE THE STENT AND DECIDED TO BALLOON THE LESION INSTEAD. WHILE THE BALLOON WAS BEING PREPPED, THE PATIENT BEGAN EXPERIENCING CHEST PAIN. THE WIRE WAS IN LAD. ANGIOGRAM USED TO PLACE BALLOON AND THE PHYSICIAN NOTED CIRCUMFLEX STILL OPEN, BUT LAD LOOKED TO BE SHUT DOWN. THE PATIENT WAS ADMINISTERED 200MG NITRO AND BALLOON WAS INFLATED. PATIENT'S PRESSURE BEGAN TO FALL. ANOTHER ANGIOGRAM WAS TAKEN AND NO FLOW COULD BE NOTED IN CIRCUMFLEX AND LAD. AS PRESSURE CONTINUED TO DROP, NO EKG CHANGES WERE NOTED AND PATIENT STATED SHE FELT FINE. SHORTLY AFTER, THE PATIENT LOST CONSCIOUSNESS. PHYSICIAN REMOVED THE GUIDE CATHETER AND WIRE FROM THE PATIENT BODY AND ADMINISTERED ATROPINE AND BEGAN CPR. CODE WAS CALLED, EMERGENCY TEAM WORKED FOR 45 MINUTES, BUT THE PATIENT WAS UNRESPONSIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE TRANSDUCER, PRESSURE, CATHETER TIP DQX VOLCANO CORPORATION 8185J 115 01037

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death