BEUDAMED
    FDA Adverse Event Death Summary report: N

    SWAN-GANZ PACING TD CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 1337353 · Received February 27, 2009

    Report

    Report Number
    2015691-2009-09984
    Event Type
    Death
    Date Received
    February 27, 2009
    Date of Event
    January 29, 2009
    Report Date
    January 30, 2009
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K791183
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AT THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONSULTANT DESCRIBED TO PUT IN THE D200HF7 PACING SWAN-GANZ CATHETER INTO A PATIENT. THE PATIENT WAS IN ICU. SHE HAD VERY SEVERE HEART FAILURE ON A ILVAD AND WAS ALSO VERY BRADYCARDIA FOR A PERIOD OF TIME. SINCE SHE REQUIRED A SWAN A PACING SWAN WAS THOUGHT TO BE VERY USEFUL. HOWEVER, WE HAD MUCH DIFFICULTY ACHIEVING ANY SENSITIVITY AND WITH GETTING CONSISTENT OR ANY CAPTURE. THE CATHETER WAS REPOSITIONED MANY TIMES BUT NO PACING WAS CAPTURED. DEVICE DISCARDED. THE PATIENT DIED THE NEXT DAY DUE TO COMPLICATIONS OF HER HEART FAILURE - THE CONSULTANT DID NOT ATTRIBUTE HER DEATH TO THE PACING SWAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ PACING TD CATHETER WITH AMC THROMBOSHIELD PACING CATHETER DYG EDWARDS LIFESCIENCES, PR D200HF7 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death