BEUDAMED
    FDA Adverse Event Other Summary report: N

    PATHFINDER 16, 2-6-2, 135CM

    MDR report key: 205030 · Received January 5, 1999

    Report

    Report Number
    2951009-1998-00002
    Event Type
    Other
    Date Received
    January 5, 1999
    Date of Event
    December 2, 1998
    Report Date
    December 28, 1998
    Manufacturer
    CARDIMA, INC.
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CHEST X-RAY OF PT SHOWED THAT THE TIP OF A PATHFINDER WAS LODGED IN THE SOFT TISSUE IN THE SUBCLAVIAN VEIN ACCESSORY PATHWAY. PHYSICIAN STATES THAT IT "APPARENTLY WAS SHEARED OFF DURING REMOVAL BY EITHER THE GUIDE OR INTRODUCER SHEATH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATHFINDER 16, 2-6-2, 135CM PATHFINDER DRF CARDIMA, INC. 01-161002 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other