BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWAN GANZ CATHETER

    MDR report key: 6186082 · Received December 19, 2016

    Report

    Report Number
    2015691-2016-03795
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 5, 2016
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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. LOT NUMBER WAS NOT PROVIDED; THEREFORE REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. INVASIVE PROCEDURES INVOLVE SOME PATIENT RISKS. ALTHOUGH SERIOUS COMPLICATIONS ARE RELATIVELY UNCOMMON, THE PHYSICIAN IS ADVISED, BEFORE DECIDING TO INSERT OR USE THE CATHETER, TO CONSIDER THE POTENTIAL BENEFITS IN RELATION TO THE POSSIBLE COMPLICATIONS. THE TECHNIQUES FOR INSERTION, METHODS OF USING THE CATHETER TO OBTAIN PATIENT DATA INFORMATION, AND THE OCCURRENCE OF COMPLICATIONS IS WELL DESCRIBED IN THE LITERATURE. 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 OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. THE 510K NUMBER IS UNKNOWN AS THE MODEL AND LOT NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PRESENTED WITH CHRONIC CHEST PAIN. COMORBIDITIES INCLUDED CONGENITAL SEPTAL DEFECT, SEVERE AORTIC REGURGITATION AND ¿CARDIAC FUNCTION CAPACITY II¿. THE PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT AND TEMPORARY PACEMAKER INSERTION. POST-OP DAY 1 A SWAN GANZ CATHETER WAS PLACED VIA THE JUGULAR VEIN. AFTER AN UNKNOWN PERIOD OF TIME, ATTEMPTS WERE MADE TO WITHDRAW THE CATHETER WITHOUT SUCCESS. CHEST X-RAY REVEALED A 6MM KNOT IN THE CATHETER. A DELIVERY SHEATH WAS DEPLOYED INTO THE SUPERIOR VENA CAVA. THE KNOTTED SWAN GANZ CATHETER WAS RE-CAPTURED BY THE END-HOLE CATHETER AND A SNARE. NO PATIENT COMPLICATIONS WERE DOCUMENTED. THIS INFORMATION WAS DOCUMENTED IN THE JOURNAL OF ANAESTHESIOLOGY INTENSIVE THERAPY PUBLISHED ONLINE 10-27-2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836747 SWAN GANZ CATHETER CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR SWAN GANZ UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 Required Intervention