BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 16195810 · Received January 18, 2023

    Report

    Report Number
    3010617000-2023-00052
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    September 18, 2022
    Report Date
    January 18, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ICY CATHETER ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. THE CUSTOMER DISPOSED THE CATHETER. SINCE THE DEVICE WAS NOT RETURNED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. EVENT OF DVT WAS ASSESSED AS SERIOUS BECAUSE BASED ON AVAILABLE INFORMATION, TREATMENT WAS REQUIRED. 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 IN 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 ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR WITH 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

    AS REPORTED, AFTER REMOVING THE ICY CATHETER (LOT #UNKNOWN) FROM A 20-YEAR-OLD MALE PATIENT WHO WAS TRANSPORTED AFTER HANGING. D-DIMER INCREASED, AND THROMBOSIS WAS FOUND FROM CATHETER INSERTION SITE TO RENAL VEIN INFLOW BY CT SCAN. HEPARIN INJECTION AND THROMBOLYSIS BEGAN. PER REPORTER, THE ICY CATHETER INSERTION WAS SMOOTH INTO THE RIGHT FEMORAL VEIN BY A EXPERIENCED PHYSICIAN WITH ZOLL PRODUCTS. THE PATIENT IS ALIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978366 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION 8700-0782-03 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male Other