BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA)

    MDR report key: 6065029 · Received October 28, 2016

    Report

    Report Number
    2015691-2016-03220
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 5, 2016
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    PMA / PMN Number
    K822723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION; IT WAS DISCARDED AT THE HOSPITAL. WITHOUT RETURN OF THE UNIT IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THESE CATHETERS ARE TYPICALLY INSERTED IN PATIENTS WHO ARE EITHER BRADYCARDIC OR ARE UNDERGOING A DIAGNOSTIC PROCEDURE AND NEED TO BE TEMPORARILY PACED. THEY CAN ALSO BE PLACED EMERGENTLY WHEN A PATIENT IS EXPERIENCING HEMODYNAMIC INSTABILITY. THEREFORE, A POOR CONNECTION WITH THE PINS COULD LEAD TO A DELAY IN PACING, CAUSING PROLONGED PERIODS OF BRADYCARDIA OR HYPOTENSION, WHICH HAS THE POTENTIAL TO BE ASSOCIATED WITH POOR PATIENT OUTCOMES. LOT NUMBER WAS NOT PROVIDED, THEREFORE REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DINAPT ADAPTER DISCONNECTED FROM A SWAN GANZ PACING CATHETER DUE TO A ¿POOR CONNECTION¿ BETWEEN THE RED SHROUDED PINS AND THE BLACK SILICONE. IT WAS FURTHER INDICATED THAT THE CUSTOMER USED TAPE TO TIGHTEN THE CONNECTION. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714924 SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA) CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR D97120F5

    Patients

    Seq Age Sex Outcome Treatment
    1 82