BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIDGEPOINT MEDICAL, INC. CROSSBOSS CATHETER

    MDR report key: 2503075 · Received March 21, 2012

    Report

    Report Number
    3007210311-2012-00001
    Event Type
    Injury
    Date Received
    March 21, 2012
    Date of Event
    February 21, 2012
    Report Date
    March 19, 2012
    Manufacturer
    BRIDGEPOINT MEDICAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K081130
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN AN EFFORT TO UNDERSTAND AND ACCURATELY CHARACTERIZE BRIDGEPOINT MEDICAL DEVICE INVOLVEMENT, BRIDGEPOINT DEVICE EXPERIENCE COORDINATOR CONTACTED DR. (B)(6) (ON (B)(4) 2012 AT 4:50 PM) WHO FELT THAT THE EVENT COULD POSSIBLY BE ATTRIBUTED TO THE BRIDGEPOINT MEDICAL CROSSBOSS CATHETER AS IT TRAVERSED INTO A SIDE BRANCH.

    Description of Event or Problem · 1

    THE PATIENT WAS BEING TREATED FOR A CHRONIC TOTAL OCCLUSION OF THE RCA WITH THE BRIDGEPOINT MEDICAL CROSSBOSS CATHETER. THE CROSSBOSS CATHETER TRAVERSED THE LESION INTO A SIDE BRANCH THAT PARALLELED THE DISTAL MAIN VESSEL. THE CROSSBOSS WAS REMOVED AND A 3.0MM BALLOON CATHETER WAS POSITIONED IN WHAT WAS THOUGHT TO BE THE DISTAL MAIN VESSEL, INFLATED TO 12 ATM (VESSEL SIZE WAS NOT REPORTED). UPON DEFLATION OF THE BALLOON CATHETER, A LARGE DISSECTION AND PERFORATION WITH CONTRAST EXTRAVASATION WAS NOTED FROM THE SIDE BRANCH. THE PATIENT REQUIRED SURGERY TO BYPASS THE VESSEL. THE CROSSBOSS CATHETER TRANSVERSED THE LESION WITHOUT DIFFICULTY AND A GUIDEWIRE WAS EXITED OUT THE DISTAL END OF THE CROSSBOSS CATHETER, IT MOVED FREELY INTO WHAT WAS FELT TO BE THE DISTAL MAIN VESSEL. THE CROSSBOSS CATHETER WAS REMOVED AND A 3.0 MM BALLOON WAS POSITIONED ACROSS THE LESION AND INFLATED TO 12 ATM, UPON DEFLATION OF THE DEVICE, A LARGE DISSECTION AND OBTUSE MARGINAL PERFORATION WITH CONTRAST MEDIUM EXTRAVASATION WAS NOTED. THE PATIENT WAS OBSERVED, THE HEPARIN WAS ALLOWED TO REVERSE NATURALLY. DURING THIS TIME, A LAD STENT PLACED 30 DAYS PRIOR CLOTTED OFF WHICH REQUIRED THROMBECTOMY TREATMENT. THE PATIENT THEN FURTHER BECAME HEMODYNAMICALLY UNSTABLE AND A PERICARDIALCENTESIS WAS PERFORMED WITH SMALL AMOUNT OF FLUID WITHDRAWN. AN IMPELLA VENTRICLE ASSIST DEVICE WAS PLACED WHICH HELPED STABILIZE THE PATIENT AND THREE (3) GRAFTMASTER STENTS WERE DEPLOYED IN THE RCA AND OM TO CLOSE OFF THE VESSEL. THE PATIENT REQUIRED CABG TO BYPASS THE PERFORATED ARTERY. THE PATIENT DID WELL POST CABG AND WAS RELEASED TO HOME IN STABLE CONDITION SIX DAYS POST EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention