BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRIDGEPOINT MEDICAL, INC CROSSBOSS CATHETER

    MDR report key: 2743983 · Received September 12, 2012

    Report

    Report Number
    3007210311-2012-00006
    Event Type
    Death
    Date Received
    September 12, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 12, 2012
    Manufacturer
    BRIDGEPOINT MEDICAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K102725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN AN EFFORT TO UNDERSTAND THE CTO CROSSING PROCEDURAL STEPS THAT LEAD TO THE EVENT, ON (B)(6) 2012, (B)(6) REVIEWED THE INTRA-PROCEDURAL FILMS, HE SUGGESTS THAT THE ANATOMY AT THE PROXIMAL CAP OF THE CTO WAS VERY DIFFICULT TO UNDERSTAND DUE TO AN ANGULATION OF THE CORONARY ARTERY AND THE LOCATION OF SIDE BRANCHES. HE BELIEVES THAT THE CROSSBOSS CATHETER WAS ERRONEOUSLY PLACED INTO A SMALL SIDE BRANCH NEAR THE PROXIMAL CAP AND UPON ADVANCEMENT INTO THE BRANCH, THE CROSSBOSS CATHETER OR THE GUIDE WIRE USED TO RE-DIRECT THE CROSSBOSS CATHETER RUPTURED THIS SMALL VESSEL THUS BEING THE CAUSATION OF THE EVENT.

    Description of Event or Problem · 1

    DURING A PROCEDURE IN WHICH THE BRIDGEPOINT CROSSBOSS CATHETER WAS USED A PT SUFFERED A MYOCARDIAL INFARCTION, ARRESTED AND EXPIRED. IN A PROCEDURE ON AN LAD CHRONIC TOTAL OCCLUSION WITH THE PROXIMAL CAP OF THE OCCLUSION LOCATED AT A DIAGONAL BRANCH, THE PHYSICIAN STARTED THE CASE WITH A CROSSBOSS CATHETER WHICH TRAVERSED INTO A BRANCH OF THE LAD PARALLEL TO THE LAD. THE CROSSBOSS CATHETER WAS REPOSITIONED AT A MORE PROXIMAL POINT AND A PILOT 200 GUIDEWIRE WAS INTRODUCED IN AN EFFORT TO RE-DIRECT THE CROSSBOSS INTO THE MAIN CHANNEL OF THE LAD. AFTER GUIDEWIRE MANIPULATIONS AN ANGIOGRAM WAS PERFORMED TO CHECK PLACEMENT OF THE DEVICES, THIS REVELED A CONTRAST STAIN SUGGESTING THAT EITHER THE CROSSBOSS CATHETER OR THE GUIDEWIRE HAD PERFORATED THE CORONARY ARTERY. AN ECHOCARDIOGRAM PERFORMED DURING THE PROCEDURE SHOWED A PERICARDIAL EFFUSION AND AS A PRECAUTIONARY MEASURE AGAINST CARDIAC TAMPONADE A PERICARDIOCENTESIS WAS PERFORMED. THE INITIAL ACCESS (TAP) OF THE PERICARDIUM RETURNED A SIGNIFICANT VOLUME OF BLOOD AND WITH THIS RESULT THE DECISION WAS MADE TO REVERSE THE HEPARIN (ANTICOAGULATION) WITH PROTAMINE. SOON AFTER THE REVERSAL OF ANTICOAGULATION THERAPY IT WAS NOTED THAT DURING THE INITIAL TAP THE NEEDLE WAS INSERTED INTO THE RIGHT VENTRICLE AND NOT THE PERICARDIAL SAC, ONCE THE ACCESS ERROR WAS RECOGNIZED A SUCCESSFUL PERICARDIOCENTESIS WAS PERFORMED. THE PHYSICIAN THEN ATTEMPTED TO RESOLVE THE PERFORATION WITH THE DEPLOYMENT OF A JOMED STENT GRAFT, DUE TO THE CHALLENGING ANATOMY, THE STENT GRAFT WAS UNABLE TO BE POSITIONED AND DEPLOYED TO THE INTENDED IMPLANT SITE. DURING THIS ATTEMPT TO POSITION THE STENT GRAFT, THROMBUS FORMED IN THE LEFT CIRCUMFLEX ARTERY AND POSSIBLY ALSO IN THE LAD. THE PT BECAME HEMODYNAMICALLY UNSTABLE AND SUFFERED A MYOCARDIAL INFARCTION WITH CARDIAC ARREST. ATTEMPTS TO RESUSCITATE THE PT WERE UNSUCCESSFUL AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIDGEPOINT MEDICAL, INC CROSSBOSS CATHETER CROSSBOSS DQY BRIDGEPOINT MEDICAL INC. M2000 BP20121150065

    Patients

    Seq Age Sex Outcome Treatment
    1 Death