BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUTTING BALLOON

    MDR report key: 298704 · Received October 4, 2000

    Report

    Report Number
    2024805-2000-00005
    Event Type
    Death
    Date Received
    October 4, 2000
    Date of Event
    September 20, 2000
    Report Date
    October 3, 2000
    Manufacturer
    INTERVENTIONAL TECHNOLOGIES INC
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.5 MM X 10 MM CUTTING BALLOON WAS USED TO TREAT A LAD-MID LESIONL. AFTER TWO INFLATIONS CINE RESULTS WERE "EXCELLENT". CASE PROCEDED AS NORMAL. TWO MINUTES AFTER SHEATH REMOVAL THE PT DIED. AUTOPSY WAS CONDUCTED, BUT THE RESULTS WERE NOT AVAILABLE TO INTRAVENOUS TRANSFUSION.

    Description of Event or Problem · 1

    INTERVENTIONAL TECHNOLOGIES OBTAINED THE AUTOPSY REPORT ON 02/02/2001 FOR THE EVENT DETAILED IN ORIGINAL MEDWATCH REPORT. CAUSE OF TP'S DEATH WAS STATED AS "CARDIAC TAMPONADE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING BALLOON PTCA LOX INTERVENTIONAL TECHNOLOGIES INC B135010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death PHYSICIAN THEN USED B135010.| B130010 WAS USED FIRST BUT WAS UNDERSIZED,