BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAZE LINEAR CARDIAC REUSABLE PROBE

    MDR report key: 1871323 · Received October 8, 2010

    Report

    Report Number
    3003502395-2010-00007
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    August 17, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ATRICURE, INC.
    Product Code
    GEH
    PMA / PMN Number
    K811390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE MAZE CARDIAC REUSABLE PROBE WAS MANUFACTURED BY COOPER SURGICAL, INC IN OCTOBER 2007. THE MAZE CARDIAC REUSABLE PROBES WERE ACQUIRED BY ATRICURE ON 8 AUGUST 2007. THE FIRST MAZE CARDIAC REUSABLE PROBES ATRICURE BUILT WAS IN (B)(6) 2008. THE LOT NUMBER 100717 IS NOT AN ATRICURE LOT NUMBER, WHICH INDICATES THAT THE PRODUCT WAS MANUFACTURED BY COOPER SURGICAL, INC. THE MAZE CARDIAC REUSABLE PROBE WITH (B)(4) WAS RETURNED TO ATRICURE FOR REPAIR ON (B)(6)2010. NO DETAILS OF THE CASE ON (B)(6)2010 WERE PROVIDED TO ATRICURE AT THAT TIME.

    Description of Event or Problem · 1

    DURING THE INITIAL PROCEDURE ON (B)(6)2010, A MAZE LINEAR CARDIAC REUSABLE PROBE WAS CONNECTED TO A CCS-200 CRYOSURGICAL SYSTEM. WHEN THE PRESSURE OF THE NITROUS OXIDE TANKS REACHED 800 POUNDS PER SQUARE INCH (PSI), THE PROBE THEN LEAKED AND DAMAGED THE HOUSING, AND IT WAS REPORTED TO HAVE BLOWN APART. THIS WAS NOT REPORTED TO ATRICURE AND WE BECAME AWARE OF THIS INCIDENT THROUGH CORRESPONDENCE FROM COOPER SURGICAL RECEIVING NOTICE FROM THE FDA. THERE WAS NO PATIENT OR USER CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAZE LINEAR CARDIAC REUSABLE PROBE UNIT, CRYOSURGICAL, ACCESSORIES GEH ATRICURE, INC. 3011 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other