BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM SOLEX 7 CATHETER

    MDR report key: 19327281 · Received May 15, 2024

    Report

    Report Number
    3010617000-2024-00426
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    May 6, 2024
    Report Date
    May 15, 2024
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075312
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SOLEX 7 CATHETER ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER. THEREFORE, A PHYSICAL INVESTIGATION OF THE CATHETER COULD NOT BE PERFORMED. EVENT OF DVT AND STROKE WAS ASSESSED AS SERIOUS AS IT WAS LIFE-THREATENING. EVENT ASSESSED AS POSSIBLY RELATED TO THE ZOLL CATHETER BECAUSE LOCATION WAS RELEVANT. CLINICAL CONDITION OF THE PATIENT CONTRIBUTED INTO DEVELOPMENT OF DVT AND STROKE. DVT IS A KNOWN COMPLICATION OF CENTRAL CATHETERS OF ANY KIND. PATIENTS IN A CRITICAL CONDITION ARE TREATED WITH IVTM. IN SUCH CASES, THOSE CONDITIONS MAKE THE PATIENTS PREDISPOSED TO THROMBOGENICITY. DEVELOPMENT OF THROMBUS IS A COMMON COMPLICATION IS SUCH PATIENT POPULATION. CRITICALLY ILL PATIENTS ARE AT INCREASED RISK OF VTE BECAUSE OF THE PRESENCE OF MULTIPLE PREDISPOSING FACTORS [W. GEERTS, ET AL. VENOUS THROMBOEMBOLISM AND ITS PREVENTION IN CRITICAL CARE. J CRIT CARE, 17 (2002), PP. 95-104]. THE RATE OF THROMBOSIS FOR CRITICAL CARE PATIENTS RECEIVING CVCS RANGES FROM 20 TO 30%, PATIENTS WITH PERIPHERAL CENTRAL CATHETERS HAD A SIGNIFICANTLY HIGHER INCIDENCE RATE OF DVT THAN PATIENTS WITH CVC (27.2% VS 9.6%, P=0.0012). THE RATE OF DVT IN THE PATIENT POPULATION RECEIVING IVTM POST-CARDIAC ARREST IS 1.7%. FOUR RANDOMIZED CONTROLLED CLINICAL TRIALS CONDUCTED IN A TOTAL OF 943 PATIENTS SHOWED THAT THERE WAS NO DIFFERENCE IN THE DVT RATE WHEN COMPARING ZOLL IVTM CATHETERS TO STANDARD CVCS. THE RATE OF DVT IN THE PATIENT POPULATION RECEIVING SURFACE COOLING HAS BEEN REPORTED BETWEEN 3 AND 15%. TIMELY ADMINISTRATION OF PROPHYLACTIC ANTICOAGULATION IS SAFE AND SIGNIFICANTLY REDUCES DVT RATES IN HIGH-RISK PATIENT POPULATIONS [ZOLL WHITE PAPER ON DVT]. DVT IS AN ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR WITH USAGE OF ANY CATHETER. THE EVENT IS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    A VENTILATED ICU PATIENT (53-YEAR-OLD MALE) WITH AN OPEN FORAMEN OVALE (PFO), WHO HAD BEEN RESUSCITATED FROM CARDIAC ARREST WAS PLACED INTO CONTROLLED HYPOTHERMIA BY IVTM THERAPY. A SOLEX 7 CATHETER (LOT # UNKNOWN) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN FOR TEMPERATURE MANAGEMENT. THE PATIENT WAS ON DVT PROPHYLAXIS: HEPARIN VIA PERFUSION AT 20.000 I.U. TO 1,2 ML/H. THE PATIENT HAD A NORMAL PTT BETWEEN 25 AND 38 SEC. (25 SEC.) AND A NORMAL QUICK TEST BEFORE THE INITIATION OF IVTM THERAPY. NO ADJUNCTIVE TEMPERATURE MANAGEMENT OR RELATIVE PROCEDURES WERE PERFORMED, AND NO OTHER CENTRAL VENOUS CATHETERS (CVC) WERE PLACED BEFORE UTILIZING THE ZOLL CATHETER. THE CATHETER FUNCTIONED AS INTENDED DURING THE SEVEN DAYS OF TREATMENT. ONE AND A HALF DAYS AFTER THE REMOVAL OF THE SOLEX 7 CATHETER, ULTRASOUND, AND CLINICAL SYMPTOMS REVEALED THROMBOSIS IN THE INTERNAL JUGULAR VEIN UP TO THE RIGHT ARM. PER THE REPORTER, SEVERAL FACTORS LIKELY CONTRIBUTED TO THE PATIENT HAVING FIVE STROKE FOCI IN THE CIRCLE OF WILLIS (CCT). THESE FACTORS INCLUDE A LARGE BLOOD CLOT (THROMBOSIS) EXTENDING FROM THE RIGHT JUGULAR VEIN UP TO THE RIGHT ARM, AN OPEN FORAMEN OVALE (PFO), AND A RECENT CARDIAC CATHETERIZATION PROCEDURE. THE INITIAL COURSE OF ACTION INVOLVED MAINTAINING THE HEPARIN THERAPY THROUGH A PERFUSOR, WITH EXTREME CAUTION TO PREVENT ANY INSTANCES OF BLEEDING. A CARDIAC CT SCAN (CCT) AND A CHEST CT SCAN FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED. CURRENT CONDITION OF THE PATIENT: VENTILATED, NOT AWAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514759 ZOLL IVTM SOLEX 7 CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593AE UNKNOWN 00849111075312

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other