BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER WITH ATRIAL PORT

    MDR report key: 6036748 · Received October 18, 2016

    Report

    Report Number
    2015691-2016-03089
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    September 18, 2016
    Report Date
    September 19, 2016
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    PMA / PMN Number
    K822723
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION AND THE CUSTOMER WAS AWARE OF THE PRODUCT CONFIGURATION CHANGE. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED, WHEN PREPARING THE PATIENT FOR INSERTION OF A SWAN GANZ PACING CATHETER, IT WAS NOTED THAT THE DINAPT PINS WERE NOT INSIDE THE PACKAGE AS THEY USED TO BE, THEREFORE "CAUSING AN ISSUE DURING AN EMERGENT SITUATION". THE CUSTOMER KNEW OF THE CHANGE IN THE PRODUCT CONFIGURATION WHERE THE DINAPT PINS WERE IN A SEPARATE PACKAGE HOWEVER THEY ASSUMED THAT THE CHANGE HAD NOT OCCURRED YET. AN OLDER PACING CATHETER KIT WAS LOCATED THAT HAD THE DINAPT PINS. THEY WERE USED AND THE PROBLEM WAS SOLVED. THERE WERE NO ALLEGATIONS OF PATIENT INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688062 SWAN-GANZ BIPOLAR PACING CATHETER WITH ATRIAL PORT CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR D97120F5 60458854

    Patients

    Seq Age Sex Outcome Treatment
    1 Other