BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ PACING TD CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 1850621 · Received October 1, 2010

    Report

    Report Number
    2015691-2010-14138
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 3, 2010
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DTB
    PMA / PMN Number
    K791183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION REVEALED THAT THE THERMISTOR WAS FOUND TO HAVE AN INTERMITTENT OPEN CONDITION AT THE THERMISTOR BEAD WHEN FLEXING THE CATHETER TIP. ALL THROUGH LUMENS WERE PATENT WITHOUT LEAKAGE. THE BALLOON INFLATED CLEARLY, AND CONCENTRICALLY, AND REMAINED INFLATED WITHIN SPECIFICATION. THERE WAS NO VISIBLE DAMAGE TO THE CATHETER BODY. THERE WERE TWO POSSIBLE LOT NUMBERS REPORTED: 58846291 OR 58861585. LOT NO. 58846291 EXPIRATION DATE 10/31/2011; APPROXIMATE AGE OF DEVICE 5 MONTHS; MANUFACTURE DATE: 04/20/2010. LOT NO. 58861585: EXPIRATION DATE 11/30/2011; APPROXIMATE AGE OF DEVICE 4 MONTHS; MANUFACTURE DATE: 05/10/2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "ALTHOUGH THERMODILUTION CURVE LINE WAS DISPLAYED ON MONITOR DURING CARDIAC OUTPUT MEASUREMENT, THE CALCULATED CARDIAC OUTPUT VALUES WERE INACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ PACING TD CATHETER WITH AMC THROMBOSHIELD PACING CATHETER DTB EDWARDS LIFESCIENCES, PR D205HF7 POSSIBLE 58846291 OR 58861585

    Patients

    Seq Age Sex Outcome Treatment
    1