BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 14844578 · Received June 28, 2022

    Report

    Report Number
    3010617000-2022-00719
    Event Type
    Injury
    Date Received
    June 28, 2022
    Report Date
    June 28, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075213
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ICY CATHETER WAS DISPOSED BY THE CUSTOMER. SINCE THE CATHETER WAS NOT RETURNED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. PER ZOLL MEDICAL SAFETY ASSESSMENT, THIS MSA FORMS IS FOR ONE CASE OF PULMONARY EMBOLISM. ONLY LIMITED INFORMATION IS AVAILABLE. CAUSES, PROPHYLAXIS, TREATMENT OR OUTCOME ARE NOT SPECIFIED. IN GENERAL, CRITICALLY ILL PATIENTS ARE IN HIGH RISK OF DVT AND SUBSEQUENT POSSIBLE PE DUE TO IMMOBILITY. 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%. 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 AND PE IS ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR WITH USAGE OF ANY CATHETER. THE EVENT IS POSSIBLY RELATED TO DEVICE AND IT IS NOT RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    DURING IVTM THERAPY, THE CUSTOMER NOTED LEAK ON THE ICY CATHETER (LOT #UNKNOWN). THE PATIENT DEVELOPED PULMONARY EMBOLISM (PE) DURING TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044422 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893AE UNKNOWN 00849111075213

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other