BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN)

    MDR report key: 19969844 · Received August 13, 2024

    Report

    Report Number
    3010617000-2024-00678
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    August 3, 2024
    Report Date
    November 24, 2024
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ICY 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. DVT AND SUBSEQUENT PULMONARY EMBOLISM (PE) ARE KNOWN COMPLICATION OF CENTRAL CATHETERS OF ANY KIND. CRITICALLY ILL PATIENTS ADMITTED TO THE ICU ARE PRONE TO THROMBOGENICITY, MOSTLY DUE TO INFLAMMATORY STATUS POST INJURY, ABNORMAL COAGULATION, IMMOBILIZATION AND CATHETERIZATION. INSTITUTIONS SHOULD FOLLOW GUIDELINES IN DVT PREVENTION WHICH INCLUDE PHARMACOLOGICAL AND MECHANICAL METHODS. IT IS REPORTED THAT 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). DVTS ARE COMMON IN THE GENERAL NEUROSURGICAL POPULATION, AS THE RATES OF DVT RANGE FROM 19 TO 50%. THE RATE OF DVT IN THE PATIENT POPULATION RECEIVING IVTM FOR NON-CARDIAC REASONS IS 5%. 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 [ZOLL DVT WHITE PAPER]. INSTITUTIONAL IMPLEMENTATION OF STANDARD PROTOCOLS THAT INCORPORATE THESE MEASURES MAY HAVE CONTRIBUTED TO THE REDUCTION OF DVT RATE. IMPORTANTLY, THERAPEUTIC HYPOTHERMIA USING A ZOLL IVTM COOLING CATHETER PLACED IN THE FEMORAL VEIN IS NOT ASSOCIATED WITH INCREASED INCIDENCE OF DVT. IN THIS CASE, PE IS POSSIBLY RELATED TO THE ICY CATHETER DUE TO RELEVANT TIMING. AT THE SAME TIME, THE PATIENT'S CLINICAL CONDITION OF CRITICAL ILLNESS MADE HIM PREDISPOSED TO THROMBOGENICITY, DVT, AND PE WHICH ARE RELATIVELY COMMON COMPLICATION IS SUCH PATIENTS. IN ADDITION, THE PATIENT HAD IN PLACE OTHER 3 PERIPHERAL VENOUS CATHETERS, WHICH COULD POTENTIALLY CONTRIBUTE TO DEVELOPMENT OF PE. EVENT WAS SERIOUS BECAUSE OF THE MEDICAL NATURE OF THIS EVENT. ADDITIONAL INFORMATION IS REQUESTED. DVT AND PE ARE ANTICIPATED EVENTS AND COULD POTENTIALLY OCCUR WITH USAGE OF ANY CATHETER. THE EVENT OF DVT RELATIONSHIP TO THE DEVICE IS POSSIBLE AND NOT RELATED TO THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    THE ICY 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. DVT IS A KNOWN COMPLICATION OF CENTRAL CATHETERS OF ANY KIND. CRITICALLY ILL PATIENTS ADMITTED TO THE ICU ARE PRONE TO THROMBOGENICITY AND DVT, MOSTLY DUE TO INFLAMMATORY STATUS POST INJURY, ABNORMAL COAGULATION, IMMOBILIZATION AND CATHETERIZATION. INSTITUTIONS SHOULD FOLLOW GUIDELINES IN DVT PREVENTION WHICH INCLUDE PHARMACOLOGICAL AND MECHANICAL METHODS. IT IS REPORTED THAT 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). DVTS ARE COMMON IN THE GENERAL NEUROSURGICAL POPULATION, AS THE RATES OF DVT RANGE FROM 19 TO 50%. THE RATE OF DVT IN THE PATIENT POPULATION RECEIVING IVTM FOR NON-CARDIAC REASONS IS 5%. 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 [ZOLL DVT WHITE PAPER]. INSTITUTIONAL IMPLEMENTATION OF STANDARD PROTOCOLS THAT INCORPORATE THESE MEASURES MAY HAVE CONTRIBUTED TO THE REDUCTION OF DVT RATE. IMPORTANTLY, THERAPEUTIC HYPOTHERMIA USING A ZOLL IVTM COOLING CATHETER PLACED IN THE FEMORAL VEIN IS NOT ASSOCIATED WITH INCREASED INCIDENCE OF DVT. IN THIS CASE, DVT IS POSSIBLY RELATED TO THE ICY CATHETER DUE TO RELEVANT LOCATION. AT THE SAME TIME, THE PATIENT'S CLINICAL CONDITION OF CRITICAL ILLNESS MADE HIM PREDISPOSED TO THROMBOGENICITY AND DVT, WHICH IS A COMMON COMPLICATION IS SUCH PATIENTS. IN ADDITION, THE PATIENT HAD IN PLACE OTHER 3 PERIPHERAL VENOUS CATHETERS, WHICH COULD POTENTIALLY CONTRIBUTE TO DEVELOPMENT OF PE. EVENT WAS SERIOUS BECAUSE OF THE MEDICAL NATURE OF THIS EVENT. ADDITIONAL INFORMATION IS REQUESTED. DVT IS AN ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR WITH THE USAGE OF ANY CATHETER. THE EVENT OF DVT RELATIONSHIP TO THE DEVICE IS POSSIBLE AND NOT RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    A 21-YEAR-OLD MALE PATIENT (97 KG) WITH A TRAUMATIC BRAIN INJURY (TBI) WAS TREATED BY AN IVTM SYSTEM WITH AN ICY CATHETER (LOT# UNKNOWN) FOR FEVER MANAGEMENT. THE CATHETER WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT FEMORAL VEIN IN ONE ATTEMPT. THERE WERE NO OTHER CENTRAL VENOUS CATHETERS PRESENT IN THE PATIENT EXCEPT FOR 3 PERIPHERAL VENOUS CATHETERS. THE PATIENT'S BODY TEMPERATURE AT THE START OF THE TREATMENT WAS 37.9 °C, AND THE TARGET TEMPERATURE OF THE COOLING PHASE WAS SET AT 36.5 °C. AFTER 48 HOURS, WHEN THE PATIENT'S BODY TEMPERATURE WAS 36.5 °C, THE CARDIOLOGISTS AND VASCULAR SURGEONS DISCOVERED AND CONFIRMED A SMALL PULMONARY EMBOLISM VIA ULTRASOUND. THE CT SCAN COMPLETED THE FOLLOWING DAY REAFFIRMED THE DIAGNOSIS. THROMBOSIS ASPIRATION WAS DEEMED TOO RISKY, AND A CAVA FILTER WAS NOT AN OPTION DUE TO ITS EXTENSION INTO THE ATRIUM. CONSEQUENTLY, THE ICY CATHETER WAS REMOVED WHILE THE PATIENT WAS STILL INTUBATED, AND THE PATIENT WAS ANTICOAGULATED AND CLOSELY MONITORED, WITH ASPIRATION RETAINED AS AN OPTION SHOULD INSTABILITY OCCUR. ACCORDING TO THE REPORTER, DVT PROPHYLAXIS WAS NOT INITIATED WITHIN THE FIRST 48-72 HOURS FOR THIS CEREBRAL HEMORRHAGE PATIENT. BLOOD COAGULOPATHY RESULTS OBTAINED BEFORE STARTING IVTM THERAPY SHOWED AN INR OF 1.11 AND A PLATELET COUNT OF 263,000. FOLLOWING ITS REMOVAL, THE CUSTOMER DISPOSED OF THE ICY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2491893 ICY® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT EU APPLAUSE CUSTOM LUER (HEPARIN) INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. IC-3893AE UNKNOWN 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Other