BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO¿ 3 SYSTEM

    MDR report key: 1813524 · Received August 24, 2010

    Report

    Report Number
    9681484-2010-00016
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    May 19, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)
    Product Code
    DQK
    PMA / PMN Number
    K090017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ADVERSE EVENT OCCURRED POST-PROCEDURE. NO PRODUCT MALFUNCTION WAS REPORTED AND NO SERVICE WAS REQUESTED BY THE CUSTOMER. THEREFORE, NO PRODUCT EVALUATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT HAD SEVERE HYPOTENSION WHILE IN THE RECOVERY ROOM AT THE END OF AN ATRIAL FIBRILLATION PROCEDURE DONE AS PART OF THE EXPRESSO STUDY. A MODERATE AND NON-COMPRESSIVE PERICARDIAL EFFUSION WAS IDENTIFIED. SUBSEQUENTLY THE PATIENT WAS HOSPITALIZED IN INTENSIVE CARE AFTER THE PROCEDURE AND WAS TREATED WITH DOBUTREX FOR 3 DAYS. THE PERICARDIAL EFFUSION RESOLVED WITHOUT SEQUELAE ON (B)(6) 2010. THE PROGNOSIS FOR THE PATIENT WAS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTO¿ 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL) M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization