BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER

    MDR report key: 3272525 · Received August 8, 2013

    Report

    Report Number
    3007210311-2013-00005
    Event Type
    Other
    Date Received
    August 8, 2013
    Date of Event
    July 15, 2013
    Report Date
    July 19, 2013
    Manufacturer
    BRIDGEPOINT MEDICAL, A SUBSIDIARY OF BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K102725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, DR (B)(6) STATED THAT THE PATIENT HAD REMAINED STABLE OVERNIGHT AND AN ECHOCARDIOGRAM PERFORMED THAT A.M. SHOWED THAT THE PERFORATION HAD SEALED AND THERE WAS NO FURTHER EFFUSION. THE PATIENT WAS SCHEDULED TO BE DISCHARGED HOME THAT AFTERNOON.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON A CALCIFIED LEFT CIRCUMFLEX CORONARY CTO, THE PATIENT EXPERIENCED AN EPICARDIAL PERFORATION WHICH REQUIRED COILS TO BE PLACED AND A PERICARDIALCENTESIS TO TREAT. IT IS REPORTED THAT DURING A PROCEDURE ON A CTO LESION IN THE LCX, THE CROSSBOSS CATHETER WAS USED WITHOUT DIFFICULTY AND CROSSED THE CTO LESION VIA THE TRUE LUMEN INTO THE 2ND OBTUSE MARGINAL BRANCH OF THE LCX ARTERY. THE CROSSBOSS WAS RETRACTED BACK AND ANTEGRADE ATTEMPTS WERE MADE TO ACCESS THE 1ST OBTUSE MARGINAL BRANCH. THESE ATTEMPTS WERE UNSUCCESSFUL; THE DECISION WAS MADE TO ACCESS THE 1ST OM VIA A RETROGRADE APPROACH THROUGH THE EPICARDIAL COLLATERAL. THE CROSSBOSS CATHETER WAS REMOVED AND NOT USED FURTHER IN THE PROCEDURE. THE EPICARDIAL COLLATERAL WAS CROSSED USING A SION GUIDEWIRE AND A CORSAIR CATHETER, AT ONE POINT, THE CORSAIR CATHETER TIP PROLAPSED IN THE EPICARDIAL COLLATERAL AND WAS REDIRECTED BACK TO THE FORWARD POSITION AND THE PROCEDURE WAS COMPLETED WITH THE 1ST OM BEING ACCESSED AND THE CTO LESION BEING TREATED WITH STENT DEPLOYMENT RESULTING IN A SUCCESSFUL TREATMENT OF THE CTO. ALL DEVICES WERE REMOVED AND FINAL ANGIOGRAMS WERE PERFORMED WHICH SHOWED A PERFORATION WITH EXTRAVASATION IN THE EPICARDIAL COLLATERAL AT THE AREA WHERE THE TIP OF THE CORSAIR HAD PROLAPSED. AN ECHOCARDIOGRAM PERFORMED AT THIS TIME, CONFIRMED EFFUSION INTO THE PERICARDIAL SAC. THE DECISION WAS MADE TO IMPLANT OCCLUSION COILS IN THE EPICARDIAL COLLATERAL AT BOTH THE ANTEGRADE AND RETROGRADE ACCESSES. THE ANTEGRADE COILS WERE PLACED WITHOUT DIFFICULTY, SOME DIFFICULTY WAS NOTED IN PLACING THE RETROGRADE COILS AND THE DECISION WAS MADE TO PERFORM A PERICARDIALCENTESIS, THIS WAS PERFORMED WITHOUT DIFFICULTY AND THE RETROGRADE COILS WERE DEPLOYED. THE PATIENT REMAINED STABLE THROUGHOUT THE EXPERIENCE AND WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374983 BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER CROSSBOSS DQY BRIDGEPOINT MEDICAL, A SUBSIDIARY OF BOSTON SCIENTIFIC M2000 B131330078

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention