BEUDAMED
    FDA Adverse Event Death Summary report: N

    SWAN-GANZ PACING CATHETER

    MDR report key: 1832433 · Received September 13, 2010

    Report

    Report Number
    2015691-2010-14042
    Event Type
    Death
    Date Received
    September 13, 2010
    Date of Event
    June 12, 2010
    Report Date
    August 13, 2010
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE WILL BE AVAILABLE FOR EVALUATION; HOWEVER, IF THE DEVICE BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONTACTED CUSTOMER AND IT WAS INDICATED THAT THE DEVICE WAS DISCARDED AT THE HOSPITAL.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING A TROPONIN (ACCU TNI) RESULT IN THE RISK STRATIFICATION RANGE GENERATED BY THE FOR UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS DISCORDANT TO AN ALTERNATE METHOD. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Description of Event or Problem · 1

    THIS PATIENT, WITH MULTIPLE CO-MORBIDITIES, UNDERWENT A MITRAL VALVE REPLACEMENT (MEDTRONIC), AORTIC VALVE REPLACEMENT (MEDTRONIC), AND A TRICUSPID VALVE REPAIR (EDWARDS, MDR REF. 2015691-2010-14037), DURING WHICH TIME AND A SWAN-GANZ PACING CATHETER WAS INSERTED. PER THE PATIENT'S MEDICAL RECORDS (I.E. DISCHARGE SUMMARY) "HE WAS NOTED TO HAVE MISFIRING OF THE PACEMAKER VIA THE SWAN-GANZ CATHETER WHERE IT APPEARED TO HAVE AN __________ AND HE WENT INTO VENTRICULAR TACHYCARDIA, WHICH HE INITIALLY HAD A PULSE. PACING PADS WERE APPLIED AND HE QUICKLY DECLINED TO PULSELESS VT FOR WHICH HE RECEIVED LIDOCAINE, CPR AND WAS THEN DEFIBRILLATED WITH 200 JOULES AND RETURNED TO HIS JUNCTIONAL RHYTHM IN THE 50S. HE WAS AGAIN AV PACED WITH 100% CAPTURE. A LIDOCAINE DRIP WAS INITIATED. FOR THE REMAINDER OF THE DAY HE HAD NO FURTHER VENTRICULAR ARRHYTHMIA AND CONTINUED TO WEAN SLOWLY FROM HIS INOTROPIC AND VASOPRESSOR SUPPORT." TWO DAYS LATER, IT BECAME NECESSARY FOR THE PATIENT TO RECEIVE A PERMANENT PACEMAKER AS THE PATIENT WAS ASYSTOLIC UNDER THE PACING SWAN-GANZ CATHETER. FIVE DAYS AFTER ADMISSION, THE FAMILY WISHED TO WITHDRAW ALL TREATMENT ON THIS VERY ILL PATIENT. THE PATIENT LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ PACING CATHETER PACING CATHETER DQE EDWARDS LIFESCIENCES, PR CCOCATHUNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death