BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUTTING BALLOON

    MDR report key: 317096 · Received February 23, 2001

    Report

    Report Number
    2024805-2001-00002
    Event Type
    Death
    Date Received
    February 23, 2001
    Date of Event
    January 26, 2001
    Report Date
    February 23, 2001
    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 3.25MM X 15MM CUTTING BALLOON WAS USED TO TREAT THE PT'S TYPE B-2 LESION IN THE MID-LAD. THREE INFLATIONS IN TANDEM WERE PERFORMED, WITH THE LAST INFLATION AT 11 ATM FOR 126 SECONDS. UPON WITHDRAWL OF THE CUTTING BALLOON PT COMPLAINED OF S.O.B. AND CHEST DISCOMFORT. ANGIOGRAM REVEALED A SMALL VESSEL RUPTURE WITH CONTRAST MEDIA COMMUNICATING TO THE PERICARDIAL SACK. PROTOMINE WAS GIVEN AND A PERICARDIALSENTESIS WAS SUCCESSFULLY PERFORMED. PT WAS INTUBATED FOR BY-PASS SURGERY. DURING THE MOVE TO O.R. IT WAS THOUGHT THAT THE E.T. TUBE SHIFTED OUT OF THE TRACHEA AND INTO THE ESOPHAGUS RESULTING IN PT AIRWAY OBSTRUCTION FOR AN UNDETERMINED AMOUNT OF TIME. ON THE O.R. TABLE RE-INTUBATION WAS DONE AND BY-PASS SURGERY PERFORMED. EXAMINATION OF THE ATHERECTOMY SITE SHOWED PERFORATION SITE HAD SEALED ITSELF OFF AND FLOW MAINTAINED. UPON RECOVERY, PT WAS NOTED TO HAVE LACK OF BRAIN ACTIVITY. PT SUBSEQUENTLY PASSED AWAY ON 02/01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7480 CUTTING BALLOON PTCA LOX INTERVENTIONAL TECHNOLOGIES, INC. B132515 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death