BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIODYNAMIC

    MDR report key: 1220676 · Received October 31, 2008

    Report

    Report Number
    MW5008850
    Event Type
    Other
    Date Received
    October 31, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ANGIODYNAMIC
    Product Code
    DYB
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE SURGEON REMOVED THE LASER FIBER FROM THE PATIENT'S LEFT LEG AND NOTICED THAT THE TIP WAS BURNT AND THE CATHETER WAS ABOUT 4 INCHES SHORTER. USING ULTRASOUND, THE SURGEON LOCATED THE MISSING PORTION OF THE FIBER IN THE PATIENT'S LEG. THE SURGEON SURGICALLY REMOVED THE RETAINED PORTION. THIS DEVICE WAS USED ON BOTH LEGS OF THE SAME PATIENT BY DR. SHEELA PETEL. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: ENDOVASCULAR RADIOFREQUENCY ABLATION BIL. GREATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIODYNAMIC VENACURE KIT DYB ANGIODYNAMIC 65CM 954071

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR