BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHFINDER

    MDR report key: 1249049 · Received November 22, 2008

    Report

    Report Number
    1249049
    Event Type
    Malfunction
    Date Received
    November 22, 2008
    Date of Event
    October 21, 2008
    Report Date
    November 22, 2008
    Manufacturer
    CARDIMA INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN STATED THAT THE TIP OF THE CATHETER WAS DEFECTIVE PRIOR TO USE. HANDED OVER NEW CATHETER. NO HARM CAME TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATHFINDER CATHETER, EP, MAPPING DRF CARDIMA INC. NA M3426

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR