BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRA 2 MONORAIL CUTTING BALLOON

    MDR report key: 926049 · Received October 10, 2007

    Report

    Report Number
    3004878732-2007-00046
    Event Type
    Death
    Date Received
    October 10, 2007
    Date of Event
    September 13, 2007
    Report Date
    September 13, 2007
    Manufacturer
    BSC LETTERKENNY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS CONFIRMED THAT THIS DEVICE HAS BEEN DISPOSED OF; THEREFORE, NO DIRECT PRODUCT ANALYSIS CAN BE COMPLETED AND NO ROOT CAUSE DETERMINATION CAN BE MADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE FOLLOWING A VESSEL PERFORATION, THE PT DIED. THE LESION BEING TREATED WAS LOCATED IN THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING ARTERY INTO THE DIAGONAL. THE PT HAD PREVIOUSLY HAD 5 TAXUS STENTS PLACED APPROX ONE WEEK BEFORE; THESE STENTS WERE LOCATED UPSTREAM FROM THE BIFURCATION BEING TREATED IN THIS PROCEDURE AND WERE UNRELATED TO THIS EVENT. THE PT PRESENTED WITH ANGINA. THE VESSEL DIAMETER WAS APPROX 2.5MM. THE CUTTING BALLOON WAS SUCCESSFULLY INFLATED TO 4.0 ATMS WITH NO LEAKS AND NOT ISSUES WITH INFLATION OR DEFLATION. THE PERFORATION WHICH THEN OCCURRED WAS ATTRIBUTED TO "BALLOON INFLATION COMBINED WITH STIFFNESS OF VESSEL" ATTEMPTS WERE MADE TO TAMPONADE THE PERFORATIONS WITH MULTIPLE INFLATIONS AND DEFLATIONS WITHOUT SUCCESS. PT WAS NOT A CANDIDATE FOR SURGERY (FAMILY REFUSED) OR ANOTHER STENTING PROCEDURE TO TREAT THE PERFORATION. REPORTED CAUSE OF DEATH "CORONARY ARTERY PERFORATION DURING A CORONARY PROCEDURE." ADD'L INFO WAS REQUESTED REGARDING THIS EVENT; HOWEVER, NONE WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA 2 MONORAIL CUTTING BALLOON LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BSC LETTERKENNY NA EH0663

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death