BEUDAMED
    FDA Adverse Event Other Summary report: N

    HALO360 ABLATION CATHETER

    MDR report key: 864221 · Received June 12, 2007

    Report

    Report Number
    3004904811-2007-00001
    Event Type
    Other
    Date Received
    June 12, 2007
    Date of Event
    May 16, 2007
    Report Date
    June 12, 2007
    Manufacturer
    BARRX MEDICAL, INCORPORATED
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY EVALUATED THE FOLLOWING: THE PHYSICIAN FEEDBACK. CATHETERS FROM FG INVENTORY FROM SUBSEQUENT LOTS AND THE PERFORMANCE OF THE CATHETER IN AN ANIMAL MODEL. IN ALL CASES, THE PRODUCT MET THE SPECIFICATION AND/OR PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON 5/16/2007, THAT A PATIENT REPORTED MILD SYMPTOMS OF DYSPHAGIA ONE MONTH AFTER TREATMENT; THE PATIENT WAS EVALUATED AND A MILD STRICTURE WAS NOTED IN THE AREA OF PREVIOUSLY TREATED DISEASE. THE PATIENT UNDERWENT ONE NON-SURGICAL, ENDOSCOPIC DILATION RESULTING IN RESOLUTION OF THE STRICTURE AND SYMPTOMS. THE PHYSICIAN CONFIRMED THAT THE EVENT WAS NOT RELATED TO ANY MALFUNCTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO360 ABLATION CATHETER COAGULATION CATHETER GEI BARRX MEDICAL, INCORPORATED NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention RF GENERATOR