BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHFINDER 16

    MDR report key: 2598404 · Received May 15, 2009

    Report

    Report Number
    2951009-2009-00556
    Event Type
    Malfunction
    Date Received
    May 15, 2009
    Date of Event
    March 30, 2009
    Report Date
    May 14, 2009
    Manufacturer
    CARDIMA, INC.
    Product Code
    DRF
    PMA / PMN Number
    K955802
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFG DOCUMENTS EXAMINED.

    Description of Event or Problem · 1

    CATHETER TIP SEPARATED WHILE IN THE HEART, REQUIRING RETRIEVAL. NO SUBSEQUENT PT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATHFINDER 16 ELECTROPHYSIOLOGY MAPPING CATHETER DRF CARDIMA, INC. 01-161003 M3547

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention