BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ HI-SHORE TRUE SIZE THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    MDR report key: 2221099 · Received August 23, 2011

    Report

    Report Number
    2015691-2011-16095
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    June 26, 2011
    Report Date
    August 1, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K812563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CATHETER WAS RECEIVED WITH A NON-EDWARDS CONTAMINATION SHIELD ATTACHED TO THE CATHETER; THE PROXIMAL END WAS APPROXIMATELY 109CM FROM THE TIP. THE CONTAMINATION SHIELD CONNECTIONS WERE TIGHT ON THE CATHETER BODY. UPON REMOVAL OF THE CONTAMINATION SHIELD, THE CATHETER BODY APPEARED COLLAPSED APPROXIMATELY 67CM AND 109CM FROM THE TIP. THE COLLAPSED CATHETER BODY APPEARED TO BE DUE TO OVER TIGHTENING OF THE CONTAMINATION SHIELD CONNECTORS. SOME RESISTANCE WAS OBSERVED WHILE INFLATING THE BALLOON BUT THE BALLOON INFLATED CLEARLY AND CONCENTRICALLY AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. RESISTANCE WAS ALSO NOTED DURING DEFLATION. A CUT-DOWN OF THE CATHETER FOUND THAT ALL LUMENS WERE COLLAPSED. PRESSURE TUBING WAS ATTACHED TO THE PA DISTAL AND PROXIMAL INJECTATE HUBS; TESTING WAS DONE WITH THE ATTACHED TUBING. ALL THROUGH LUMENS WERE TESTED FOR PATENCY AND LEAKAGE. THE PA DISTAL LUMEN WAS PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THE PROXIMAL INJECTATE LUMEN WAS FOUND TO BE OCCLUDED WITH WHAT APPEARED TO BE BLOOD. THERE WAS NO VISIBLE DAMAGE OBSERVED ON THE RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. VISUAL EXAMINATION WAS PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION. THE COMPLAINT WAS CONFIRMED; HOWEVER, NO EVIDENCE OF A MANUFACTURING DEFECT WAS FOUND. IT APPEARS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT THE BALLOON HAD INCREASED RESISTANCE, A WEDGE PRESSURE COULD NOT BE OBTAINED, AND THERE WAS AN INABILITY TO MONITOR THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ HI-SHORE TRUE SIZE THERMODILUTION CATHETER WITH AMC THROMBOSHIELD THERMODILUTION CATHETER DYG EDWARDS LIFESCIENCES, PR 141HF7

    Patients

    Seq Age Sex Outcome Treatment
    1