BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION PACEPORT CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 2864184 · Received December 10, 2012

    Report

    Report Number
    2015691-2012-18808
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    LDF
    PMA / PMN Number
    K803058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER IS EXPECTED TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED PRODUCT REFUTED THE CUSTOMER REPORT OF "BALLOON IN THE TIP OF THE CATHETER WAS MISSING". BALLOON LEAKAGE WAS IDENTIFIED THROUGH A TEAR, ABOUT 0.040" IN LENGTH PROXIMAL OF THE DISTAL BOND. THE BALLOON WAS IMMERSED IN WATER AND PRESSURIZED WITH AIR TO VISUALLY DETERMINE THE SOURCE OF LEAKAGE. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE WAS OBSERVED ON CATHETER BODY. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED DURING THE EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. IT COULD NOT BE DETERMINED IF PROCEDURAL FACTORS OR DEVICE HANDLING MAY HAVE CONTRIBUTED TO THE EVENT REPORTED. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED, THE CUSTOMER INFORMED THAT THERE WAS NO BALLOON ON THE CATHETER. ADDITIONAL INFORMATION REVEALED THAT THE EVENT OCCURRED BEFORE USE ON PATIENT. DURING SET UP, THE STAFF NOTICED THAT THE BALLOON ON THE TIP OF THE CATHETER WAS MISSING. SOME "PARTS" THAT COULD HAVE BEEN A PART OF A BALLOON WERE OBSERVED. THE CATHETER WAS NEVER IN CONTACT WITH BLOOD OR THE PATIENT. THE CATHETER WAS HANDLED UNDER STERILE CONDITIONS SO THERE IS NO CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ THERMODILUTION PACEPORT CATHETER WITH AMC THROMBOSHIELD ELECTRODE, PACEMAKER, TEMPORARY LDF EDWARDS LIFESCIENCES, PR 931HF75 59319945

    Patients

    Seq Age Sex Outcome Treatment
    1