BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM SOLEX 7 CATHETER

    MDR report key: 15633377 · Received October 19, 2022

    Report

    Report Number
    3010617000-2022-01913
    Event Type
    Injury
    Date Received
    October 19, 2022
    Date of Event
    October 11, 2022
    Report Date
    October 19, 2022
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    NCX
    UDI-DI
    00849111075312
    PMA / PMN Number
    K081936
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SOLEX CATHETER ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED BY THE CUSTOMER FOR EVALUATION. THEREFORE, A PHYSICAL INVESTIGATION OF THE CATHETER COULD NOT BE PERFORMED. IT WAS REPORTED THAT CURRENT PATIENT'S CONDITION IS STILL IN THE WARD BUT NOT BECAUSE OF THE THROMBOSIS. EVENT OF DVT WAS ASSESSED AS NOT SERIOUS, EVENT DIDN'T REQUIRE ANY TREATMENT. EVENT ASSESSED AS PROBABLY RELATED TO THE ZOLL CATHETER DUE TO RELEVANT TIMING AND LOCATION OF DVT. AT THE SAME TIME, THE PATIENT'S POST CARDIAC ARREST CONDITION AND IMMOBILITY POSSIBLY CONTRIBUTED TO DEVELOPMENT OF CURRENT CONDITION OF DVT. 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 THE USAGE OF ANY CATHETER. THE REPORTED EVENT IS PROBABLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE SOLEX CATHETER (LOT #UNKNOWN) WAS PLACED IN THE RIGHT SUBCLAVIAN OF A 50-YEAR-OLD FEMALE PATIENT WHO WEIGHED 70KG. THE CATHETER WAS SMOOTHLY INSERTED ON THE FIRST ATTEMPT AND WAS REMOVED ON (B)(6) 2022. THE PATIENT TEMPERATURE WAS 37 DEGREES, AND THE THERAPY HAD BEEN COMPLETED WITHOUT ISSUE. ON (B)(6) 2022, THE PATIENT`S RIGHT ARM WAS BLUE AND SWOLLEN, WHEREUPON THEY PERFORMED A SONOGRAM AND DISCOVERED A THROMBOSIS IN THE RIGHT SUBCLAVIAN. THERE ARE NO BLOOD COAGULOPATHY RESULTS FROM PRIOR TO INITIATION OF IVTM THERAPY. THE PATIENT WAS ON LOVENOX 80MG FOR DVT PROPHYLAXIS FROM THE BEGINNING OF THE IVTM THERAPY, WHICH IS STANDARD FOR TBI PATIENTS. THE PATIENT WAS NOT IN A HIGH-RISK CATEGORY FOR DVT AND THERE WERE NO OTHER CVC PLACEMENTS PRIOR TO INSERTION OF THE SOLEX CATHETER. NO ADJUNCT THERAPIES WERE PERFORMED. THE PATIENT DID NOT SUFFER ANY DAMAGE OR SUBSEQUENT ILLNESS DUE TO THE THROMBOSIS AND NO INTERVENTION WAS NEEDED OR PLANNED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2945688 ZOLL IVTM SOLEX 7 CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION INC SL-2593AE UNKNOWN 00849111075312

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other