BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRIDGEPOINT MEDICAL, INC CROSSBOSS CATHETER

    MDR report key: 2744009 · Received September 12, 2012

    Report

    Report Number
    3007210311-2012-00005
    Event Type
    Death
    Date Received
    September 12, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 10, 2012
    Manufacturer
    BRIDGEPOINT MEDICAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K102725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PERSONAL ACCOUNT OF THE OPERATING PHYSICIAN DR (B)(6) AND VISITING PHYSICIAN DR (B)(6) FROM (B)(6) HOSP, THIS ADVERSE EVENT WAS NOT ASSOCIATED WITH THE BRIDGEPOINT DEVICE.

    Description of Event or Problem · 1

    THE DEATH OF PT C-P WAS REPORTED TO US DUE TO THE FACT THAT A BRIDGEPOINT MEDICAL DEVICE WAS USED IN THE PROCEDURE THAT PRECIPITATED THE PT'S DEATH. THE PT WAS BEING TREATED FOR A CHRONIC TOTAL OCCLUSION OF THE RCA. THE BRIDGEPOINT CROSSBOSS WAS USED IN AN ATTEMPT TO CROSS THE LESION USING AN ANTEGRADE APPROACH. THE ANATOMY PRESENTED SIGNIFICANT CHALLENGES FOR GUIDE CATHETER SUPPORT AND LESION ACCESS. THE CROSSBOSS TRANSVERSED A PORTION OF THE LESION BUT WAS UNABLE TO ADVANCE ANY FURTHER. APPROX 1.5 HOURS INTO THE PROCEDURE THE DECISION WAS MADE TO CHANGE FROM AN ANTEGRADE APPROACH TO A RETROGRADE APPROACH VIA THE LEFT GUIDING CATHETER. NO BRIDGEPOINT DEVICES WERE USED DURING THE REMAINDER OF THE PROCEDURE. ACCESS TO THE DISTAL RCA BEYOND THE CTO VIA THE RETROGRADE APPROACH BECAME CHALLENGING AND TIME CONSUMING. AT APPROX THE 3.5 HOUR MARK OF THE PROCEDURE THE PT BECAME HYPOTENSIVE AND SUFFERED TWO EPISODES OF VENTRICULAR TACHYCARDIA REQUIRING SUCCESSFUL RESUSCITATION. THE PROCEDURE WAS ABORTED AT THIS TIME. THE PT WAS ADMITTED TO THE ICU IMMEDIATELY POST-PROCEDURE. AT APPROX 12 AM, THE PT SUFFERED ANOTHER CARDIAC ARREST AND WAS UNABLE TO BE RESUSCITATED AND EXPIRED. ECHOCARDIOGRAM PERFORMED POST-PROCEDURE SHOWED THAT THE CAUSATION FOR THE ADVERSE EVENT AROSE ON THE LEFT SIDE OF THE HEART AND WAS MOST LIKELY ASSOCIATED WITH SOME ASPECT OF THE INTERVENTION WITHIN THE LEFT HEART CIRCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIDGEPOINT MEDICAL, INC CROSSBOSS CATHETER CROSSBOSS DQY BRIDGEPOINT MEDICAL INC. M2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death