BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUTTING BALLOON

    MDR report key: 378253 · Received February 22, 2002

    Report

    Report Number
    2024805-2002-00002
    Event Type
    Death
    Date Received
    February 22, 2002
    Date of Event
    January 5, 2002
    Report Date
    February 22, 2002
    Manufacturer
    BSC - INTERVENTIONAL TECH
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN A SAPHENOUS VEIN GRAPH AT THE DISTAL ANASTOMOSIS, A CUTTING BALLOON WAS INFLATED ONCE AT UNKNOWN ATMS CAUSING A DISSECTION. PATIENT WAS TAKEN TO OR FOR EMERGENT CABG. PATIENT DIED A LATER OF CARDIAC TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING BALLOON PTCA LOX BSC - INTERVENTIONAL TECH UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *