BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCENTRIC BALLOON GUIDE CATHETER

    MDR report key: 515004 · Received March 8, 2004

    Report

    Report Number
    2954917-2004-00001
    Event Type
    Injury
    Date Received
    March 8, 2004
    Date of Event
    January 1, 2004
    Report Date
    March 8, 2004
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A DISSECTION THAT MAY HAVE BEEN CAUSED BY THE BALLOON GUIDE CATHETER. THE DISSECTION WAS STENTED. THERE IS NO FURTHER PATIENT OR EVENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCENTRIC BALLOON GUIDE CATHETER GUIDING CATHETER WITH OCCLUSION BALLOON DQY CONCENTRIC MEDICAL, INC. REF 90074 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention