BEUDAMED
    FDA Adverse Event Death Summary report: N

    CUTTING BALLOON

    MDR report key: 363876 · Received November 30, 2001

    Report

    Report Number
    2024805-2001-00015
    Event Type
    Death
    Date Received
    November 30, 2001
    Date of Event
    November 3, 2001
    Report Date
    November 27, 2001
    Manufacturer
    BSC - INTERVENTIONAL TECH
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUTTING BALLOON WAS POSITIONED IN A DIAGONAL LESION OFF OF STENTED "LAD". PHYSICIAN CROSSED THROUGH STENT INTO THE DIAGONAL. PHYSICIAN NOTED CRACKED HUB AND PULLED BACK ON CATHETER TO REMOVE/REPLACE. PHYSICIAN ATTEMPTED TO PULL CATHETER OUT BUT MET WITH RESISTANCE. FORCE WAS USED IN AN ATTEMPT TO REMOVE CATHETER. PHYSICIAN REMOVED GUIDE CATHETER AND CUTTING BALLOON TOGETHER AND THEN ATTEMPTED TO RE-ENGAGE GUIDE WIRE BUT WAS NOT ABLE TO GAIN ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53968 CUTTING BALLOON PTCA LOX BSC - INTERVENTIONAL TECH B125010 F0125502

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Death