BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CATHETER

    MDR report key: 2771237 · Received October 3, 2012

    Report

    Report Number
    2015691-2012-18389
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    June 24, 2012
    Report Date
    September 4, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED AT THE HOSPITAL; THEREFORE, A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT A PRODUCT RETURN. IT IS ALSO NOT POSSIBLE TO DETERMINE WITH CERTAINTY IF A DAMAGED THERMAL FILAMENT CAUSED THE CATHETER TO GET STUCK IN THE SHEATH OR IF THE DAMAGE WAS CAUSED WHEN THE CATHETER GOT STUCK IN THE SHEATH. AS NO ANOMALIES WERE NOTED PRIOR TO INSERTION AND NO DIFFICULTIES WITH INSERTION WERE REPORTED, IT SEEMS MORE LIKELY THAT THE DAMAGE WOULD HAVE BEEN CAUSED BY THE INTERACTION WITH THE SHEATH. NO ACTIONS WILL BE TAKEN AT THIS TIME. THE ACTUAL MODEL NUMBER WAS NOT REPORTED; THEREFORE, THE PMA/510K NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    THE REPORT INDICATED THAT THE SWAN-GANZ CATHETER BECAME STUCK IN THE ARROW INTRODUCER. THE INTRODUCER ASSEMBLY WAS PLACED IN THE RIGHT INTERNAL JUGULAR VEIN. THE CONTINUOUS CARDIAC OUTPUT CATHETER WAS FED THROUGH THE INTRODUCER IN THE USUAL MANNER. AS THE SURGERY INVOLVED A TRICUSPID VALVE ANNULOPLASTY, THE CATHETER WAS WITHDRAWN INTO THE RIGHT ATRIUM. FOLLOWING CARDIOPULMONARY BYPASS, SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO RE-FLOAT THE CATHETER. WHEN AN ATTEMPT WAS MADE TO WITHDRAW THE CATHETER, IT BECAME "STUCK" AND COULD NOT BE ADVANCED OR RETRACTED SO THE CATHETER/INTRODUCER ASSEMBLY WAS REMOVED AS A SINGLE UNIT WITH NO INJURY TO THE PATIENT. UPON REMOVAL, IT WAS NOTED THAT THE HEATING COIL ON THE SWAN-GANZ CATHETER HAD "UNRAVELED". IT WAS THE OPINION OF THE REPORTER THAT THE UNRAVELING SEEMED TO BE THE REASON FOR THE CATHETER GETTING STUCK IN THE INTRODUCER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1