BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUTTING BALLOON

    MDR report key: 384395 · Received March 26, 2002

    Report

    Report Number
    2024805-2002-00007
    Event Type
    Death
    Date Received
    March 26, 2002
    Date of Event
    February 19, 2002
    Report Date
    March 25, 2002
    Manufacturer
    BSC-INTERVENTIONAL TECH
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUTTING BALLOON RUPTURED AFTER THE SECOND INFLATION AT 8 ATM. ANOTHER CUTTING BALLOON WAS PULLED TO COMPLETE THE CASE. THE PHYSICIAN HAD DIFFICULTY REMOVING THE SECOND BALLOON FROM THE CIRCUMFLEX. THE GUIDE CATHETER MOVED FURTHER INTO THE LEFT MAIN CAUSING A DISSECTION. PATIENT WAS NOT TAKEN TO SURGERY AS PATIENT WAS NOT A GOOD SURGICAL CANDIDATE. PATIENT BECAME UNSTABLE AND EXPIRED. CAUSE OF DEATH WAS REPORTED TO BE HEMATOMA IN THE AORTA - CAUSED FROM LEFT MAIN DISSECTION EXTENDING INTO THE AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING BALLOON PTCA LOX BSC-INTERVENTIONAL TECH B125010 F0115506

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death