BEUDAMED
    FDA Adverse Event Other Summary report: N

    GUIDANT

    MDR report key: 776161 · Received October 24, 2006

    Report

    Report Number
    776161
    Event Type
    Other
    Date Received
    October 24, 2006
    Date of Event
    October 16, 2006
    Report Date
    October 23, 2006
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PTCA TO MID CIRC. WHEN WITHDRAWING BALLOON, BALLOON SEPARATED FROM SHAFT INSIDE GUIDE CATHETER. BALLOON RETRIEVAL WITHOUT DIFFICULTY. NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT POWERSAIL LOX ABBOTT VASCULAR * 6092151

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other