BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 5997845 · Received October 4, 2016

    Report

    Report Number
    2015691-2016-02922
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 12, 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

    REPORT OF "DINAPT ADAPTER DISCONNECTED" WAS NOT CONFIRMED. WHEN RECEIVED THE DIN ADAPTORS WERE TAPED TO THE ELECTRODE LEAD CONNECTORS. WHEN THE TAPE WAS REMOVED IT WAS FOUND THE DIN ADAPTORS WERE NOT FULLY ATTACHED TO THE ELECTRODE LEAD CONNECTORS. WHEN THE DIN ADAPTORS WERE FULLY SEATED THEY FIT TIGHT AND DID NOT EASILY DISCONNECT. WHEN THE DIN ADAPTORS WERE NOT FULLY SEATED THEY WERE EASY TO DISCONNECT. THERE IS ALSO 5.2CM OF THE CATHETER TIP THAT APPEARS TO HAVE BEEN CUT OFF AND NOT RETURNED. CONTINUITY TESTING AND BALLOON INFLATION COULD NOT BE PERFORMED DUE TO THE CATHETER TIP MISSING. 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. 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. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE COMPLETION OF THE PRODUCT EVALUATION. LOT NUMBER WAS NOT PROVIDED, THEREFORE, REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WITH THE EVALUATION RESULTS WHEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE IN AN UNSTABLE PATIENT, THE DINAPT ELECTRODE ADAPTER DISCONNECTED FROM A SWAN GANZ PACING CATHETER. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647841 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