BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6130651 · Received November 28, 2016

    Report

    Report Number
    2015691-2016-03511
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    November 13, 2016
    Report Date
    November 15, 2016
    Manufacturer
    EDWARDS LIFESCIENCES
    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. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. 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 PROBLEM 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. IT IS COMMON CLINICAL PRACTICE TO ENSURE THAT ALL CONNECTIONS ARE SECURE BEFORE INITIATING PACING ON A PATIENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY AND WITH PATIENT´S HEART RATE AT 15BPM, THE CUSTOMER TRIED TO CONNECT THE PROBE TO THE PULSE GENERATOR ON THE INSERTED TRANSVENOUS PACER OF THIS SWAN-GANZ BIPOLAR PACING CATHETER, BUT THE KIT HAS NO LONGER PROVIDES THE ADAPTOR IN THE SAME PACKAGE AND NONE WAS AVAILABLE, THE PHYSICIAN HAD TO MODIFY THE KIT TO USE IT AS IT HAD ALREADY BEEN INSERTED. CUSTOMER REPORTED BEING UNAWARE OF THE CHANGE BUT A LETTER WAS SENT TO THE HOSPITAL TO INFORM ABOUT THE NEW PACKAGE CHANGE. IT WAS LATER INDICATED THAT THE PATIENT WAS TRANSFERRED TO CALGARY WHERE THE PATIENT RECEIVED A PERMANENT PACEMAKER, A COUPLE DAYS FOLLOWING THE TRANSFER. THE PHYSICIAN CUT THE PLASTIC TO AROUND THE END OF THE SWAN GANZ CATHETER ALLOWING IT TO CONNECT INTO THE PULSE GENERATOR. INQUIRED OF PATIENT DEMOGRAPHICS. UNABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779185 SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA) CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES D97120F5 60458854

    Patients

    Seq Age Sex Outcome Treatment
    1