BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6178267 · Received December 15, 2016

    Report

    Report Number
    2015691-2016-03732
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 24, 2016
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    PMA / PMN Number
    K822723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE INITIAL MEDWATCH SUBMITTED THE STATEMENT OF: LOT NUMBER WAS NOT PROVIDED, THEREFORE, REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED WAS WRITTEN IN ERROR.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION; IT WAS DISCARDED AT THE HOSPITAL. 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 DELAY IN PACING MAY 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING A PATIENT RESUSCITATION IN THE CARDIAC CATH LAB, THE CLINICIAN COULD NOT LOCATE THE DINAPT ADAPTORS FOR THE SWAN GANZ BIPOLAR PACING CATHETER. THE DINAPT ADAPTORS ARE NO LONGER PACKAGED WITHIN THE SWAN GANZ PACER PACKAGE IN ORDER TO COMPLY WITH ISO 60601 REGULATION. THE PATIENT RECOVERED, BUT THE CLINICIANS HAD TO LOCATE ADAPTORS TO SOLVE THE ISSUE. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. INQUIRED OF PATIENT DEMOGRAPHICS. UNABLE TO BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830007 SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA) CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR D97120F5 60113535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other