BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENAPORT

    MDR report key: 363250 · Received November 26, 2001

    Report

    Report Number
    2951009-2001-00006
    Event Type
    Malfunction
    Date Received
    November 26, 2001
    Date of Event
    October 23, 2001
    Report Date
    November 23, 2001
    Manufacturer
    CARDIMA, INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE DISTAL TIP OF THE PRODUCT BECAME DETACHED FROM THE CATHETER BODY AND DROPPED INTO THE HEART OF THE PT. PHYSICIAN DID RETRIEVE TIP AND PT IS SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53158 VENAPORT GUIDE CATHETER DQY CARDIMA, INC. NA P1047

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention