BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE

    MDR report key: 1518856 · Received October 30, 2009

    Report

    Report Number
    3003610571-2009-00001
    Event Type
    Injury
    Date Received
    October 30, 2009
    Date of Event
    October 14, 2009
    Report Date
    October 27, 2009
    Manufacturer
    BIOCARDIA, INC.
    Product Code
    DQX
    PMA / PMN Number
    K012749
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN/USER COMMENT: CONDUCTION DISTURBANCES COMPLICATING CARDIAC CATHETERIZATION MAY BE PRECIPITATED WHEN THE CATHETER IMPACTS THE AREA OF THE RIGHT BUNDLE DURING RIGHT-SIDED HEART CATHETERIZATION; IN A PT WITH A PRE-EXISTING LEFT BUNDLE BRANCH BLOCK, THIS MAY PRODUCE COMPLETE HEART BLOCK REQUIRING TREATMENT. THE SAME SCENARIO CAN OCCUR WHEN LEFT BUNDLE BRANCH BLOCK IS PRODUCED AS THE AORTIC VALVE IS CROSSED FOR LEFT HEART CATHETERIZATION IN A PT WITH PRE-EXISTING RIGHT BUNDLE BRANCH BLOCK. ATROPINE IS RARELY HELPFUL BUT SHOULD BE GIVEN ANYWAY SINCE IT HAS FEW ADVERSE EFFECTS. THE PROPHYLACTIC USE OF TEMPORARY PACEMAKERS FOR CATHETERIZATION OF PTS WITH BUNDLE BRANCH BLOCK WAS ONCE COMMON, BUT HAS BEEN ABANDONED BECAUSE ASYSTOLE IS RARE AND THERE IS GENERALLY TIME FOR INSERTION OF A PACING CATHETER. [FROM GROSSMAN'S CARDIAC CATHETERIZATION, ANGIOGRAPHY, AND INTERVENTION, 7TH EDITION, 2006, P49.] RESULTS: NO DAMAGE OR NON-CONFORMANCES WERE OBSERVED. THE DEVICE DEFLECTS NORMALLY AND APPEARS IN PRISTINE CONDITION WITH NO APPARENT DAMAGE OR INDICATION OF WEAR DURING USE. CONCLUSIONS: THERE IS NOTHING THAT CAN BE SEEN ON THIS CATHETER THAT WOULD INDICATE THAT IT DOES NOT CONFORM TO OUR SPECS. THERE ARE NO IRREGULARITIES OR OTHER FEATURES THAT WOULD SEEM LIKELY TO CAUSE ANY INJURY OR DAMAGE TO PT ANATOMY.

    Description of Event or Problem · 1

    A SERIOUS ADVERSE EVENT OCCURRED POSSIBLY RELATED TO THE MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 00895. THE PT HAD ISCHEMIC CARDIOMYOPATHY RELATED TO PRIOR ANTERIOR WALL INFARCTION. THERE WAS BASELINE RIGHT BUNDLE BRANCH BLOCK. LEFT HEART CATHETERIZATION AND VENTRICULOGRAPHY WERE DONE WITH A 6 FRENCH 145-DEGREE ANGLED PIGTAIL CATHETER, WHICH WAS THEN PULLED BACK AND REMOVED. THERE WERE NO SIGNIFICANT ARRHYTHMIAS. THE LV WAS DILATED (224 ML) WITH POOR FUNCTION (LVEF 0.27). THE MORPH WAS ADVANCED OVER A 0.035" 3 MM-J-TIP GUIDEWIRE INTO THE LV. COMPLETE HEART BLOCK DEVELOPED IMMEDIATELY UPON ENTERING THE LV. THERE WAS BRADYCARDIA WITH JUNCTIONAL ESCAPE RHYTHM WHICH WAS ASYMPTOMATIC, AND WAS NOT RESPONSIVE TO ATROPINE IV. A TEMPORARY PACING CATHETER WAS INSERTED FROM THE RIGHT FEMORAL VEIN TO THE RIGHT VENTRICLE, AND DEMAND PACING INITIATED. THE HELICAL INFUSION CATHETER WAS INSERTED THROUGH THE MORPH AND INJECTION OF 0.5 CC EACH OF PRODUCT INTO 10 SITES IN THE INFARCT AND BORDER ZONES. ECHOCARDIOGRAPHY SHOWED NO PERICARDIAL EFFUSION. HEART BLOCK PERSISTED AND THE PT WAS TAKEN FOR IMPLANTATION OF A PACING DEFIBRILLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE GUIDE CATHETER DQX BIOCARDIA, INC. 00895 00552

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R 0.035" J-TIPPED GUIDE WIRE