BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER QWIKSTAR CATHETER

    MDR report key: 720869 · Received May 30, 2006

    Report

    Report Number
    2029046-2006-00032
    Event Type
    Injury
    Date Received
    May 30, 2006
    Date of Event
    January 31, 2006
    Report Date
    May 30, 2006
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING MAPPING WITH THE OWIKSTAR CATHTER AND THE NOGA XP3D MAPPING SYSTEM, THE PATIENT DEVELOPED CHEST PAINS AND PERICARDIAL EFFUSION. THE PERICARDIAL EFFUSION WAS EVACUATED LATER ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER QWIKSTAR CATHETER ELECTROPHYSIOLOGY CATHETER DRF BIOSENSE WEBSTER, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R