BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 12381107 · Received August 28, 2021

    Report

    Report Number
    3010617000-2021-00775
    Event Type
    Death
    Date Received
    August 28, 2021
    Date of Event
    July 8, 2021
    Report Date
    August 27, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075282
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    THE ZOLL CATHETER WAS NOT RETURNED. THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. 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 [ZOLLER B, LI X, SUNDQUIST J, ET AL. RISK OF PULMONARY EMBOLISM IN PATIENTS WITH AUTOIMMUNE DISORDERS: A NATIONWIDE FOLLOW-UP STUDY FROM SWEDEN. LANCET. 2012; 379:244-249]. 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. FOUR RANDOMIZED CONTROLLED CLINICAL TRIALS (2 MULTICENTER AND 2 SINGLE CENTER 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. [DEYE N, CARIOU A, GIRARDIE P, ET AL. ENDOVASCULAR VERSUS EXTERNAL TARGETED TEMPERATURE MANAGEMENT FOR OUT-OF-HOSPITAL CARDIAC ARREST PATIENTS: A RANDOMIZED CONTROLLED STUDY. CIRCULATIONAHA.114.012805. PUBLISHED ONLINE BEFORE PRINT JUNE 19, 2015, DOI: 10.1161/CIRCULATIONAHA.114.012805; DIRINGER MN, ET AL: TREATMENT OF FEVER IN THE NEUROLOGIC INTENSIVE CARE UNIT WITH A CATHETER-BASED HEAT EXCHANGE SYSTEM. CRIT CARE MED 2004 VOL. 32, NO. 2; WHITE PAPER EDC-2888]. THE RISK OF DEATH FROM VENOUS THROMBOEMBOLISM (VTE) IS HIGH IN INTENSIVE CARE UNIT PATIENTS WITH NEUROLOGICAL DIAGNOSES. THIS IS DUE TO AN INCREASED RISK OF VENOUS STASIS SECONDARY TO PARALYSIS AS WELL AS AN INCREASED PREVALENCE OF UNDERLYING PATHOLOGIES THAT CAUSE ENDOTHELIAL ACTIVATION AND CREATE AN INCREASED RISK OF EMBOLUS FORMATION. IN MANY OF THESE DISEASES, THERE IS AN ASSOCIATED RISK FROM BLEEDING BECAUSE OF STANDARD VTE PROPHYLAXIS. THERE IS A PAUCITY OF PROSPECTIVE STUDIES EXAMINING DIFFERENT VTE PROPHYLAXIS STRATEGIES IN THE NEUROLOGICALLY ILL. THE LACK OF A SOLID EVIDENTIARY BASE HAS POSED CHALLENGES FOR THE ESTABLISHMENT OF CONSISTENT AND EVIDENCE-BASED CLINICAL PRACTICE STANDARDS. IN RESPONSE TO THIS NEED FOR GUIDANCE, THE NEUROCRITICAL CARE SOCIETY SET OUT TO DEVELOP AND EVIDENCE-BASED GUIDELINE USING GRADE TO SAFELY REDUCE VTE AND ITS ASSOCIATED COMPLICATIONS [P. NYQUIST, C. BAUTISTA, D. JICHICI, ET AL. PROPHYLAXIS OF VENOUS THROMBOSIS IN NEUROCRITICAL CARE PATIENTS: AN EVIDENCE-BASED GUIDELINE: A STATEMENT FOR HEALTHCARE PROFESSIONALS FROM THE NEUROCRITICAL CARE SOCIETY NEUROCRIT CARE (2016) 24:47-60]. IT WAS DISCUSSED IN LITERATURE THAT IT IS IMPORTANT TO BE AWARE THAT ACUTE ICH PATIENTS ARE AT INCREASED RISK OF DEVELOPING DVT. [DEEP VENOUS THROMBOSIS AFTER ACUTE INTRACEREBRAL HEMORRHAGE; JOURNAL OF THE NEUROLOGICAL SCIENCES, VOLUME 272, ISSUES 1-2, 15 SEPTEMBER 2008, PAGES 83-86]. THERE WAS NO INFORMATION ABOUT DOSAGES OF MEDICATIONS USED FOR DVT PREVENTION TO ASSESS IF PROPHYLAXIS WAS SUFFICIENT. HOWEVER, IT IS KNOWN THAT THE USE OF ANTITHROMBOTIC THERAPIES TO PREVENT THROMBOEMBOLISM IN PATIENTS WITH AN ACUTE OR PRIOR INTRACEREBRAL HEMORRHAGE (ICH) PRESENTS A CLINICAL DILEMMA WITH COMPETING RISKS AND BENEFITS [E. WIJDICKS, J. BILLER, J WILTERDINK. THE USE OF ANTITHROMBOTIC THERAPY IN PATIENTS WITH AN ACUTE OR PRIOR INTRACEREBRAL HEMORRHAGE. HTTPS://WWW.UPTODATE.COM/CONTENTS/THE-USE-OF-ANTITHROMBOTIC-THERAPY-IN-PATIENTS-WITH-AN-ACUTE-OR-PRIOR-INTRACEREBRAL-HEMORRHAGE], SO IT WAS POSSIBLE THAT PROPHYLAXIS WAS PERFORMED IN SMALLER DOSES. IN THIS CASE, CUSTOMER HASN'T CONFIRMED IF PE ACTUALLY OCCURRED OR NOT. IT WAS SUSPECTED PEA. HOWEVER, THIS PATIENT HAD ALREADY CARDIAC ARREST EARLIER AND WAS RESUSCITATED. SURVIVAL RATE AFTER CARDIAC ARREST LESS THAN 12%. CUSTOMER QUERIED FOR ADDITIONAL INFORMATION. EVENT WAS SERIOUS DUE TO OUTCOME DEATH. EVENT POSSIBLE RELATED TO ZOLL CATHETER, ADDITIONAL INFORMATION WOULD BE HELPFUL. DVT AND PE ARE EXPECTED EVENTS WITH USAGE OF ANY INTRAVENOUS CATHETERS.

    Description of Event or Problem · 1

    A QUATTRO CATHETER WAS USED FOR IVTM THERAPY FOR A (B)(6) YEAR-OLD MALE PATIENT. THE REASON FOR THE IVTM THERAPY WAS FOR POST-CARDIAC ARREST CARE. ON (B)(6) 2021, THE QUATTRO CATHETER WAS PLACED INTO THE PATIENT'S RIGHT FEMORAL VEIN. THE PATIENT WAS COOLED DOWN TO 33°C. THE PATIENT HAD HEPARIN SUBCUTANEOUS (SQ) THREE TIMES A DAY FOR DEEP VEIN THROMBOSIS (DVT) PROPHYLAXIS. ON (B)(6) 2021, THE USER REMOVED THE CATHETER FROM THE PATIENT, AND 20 MINUTES LATER, THE PATIENT HAD A DROP IN BLOOD PRESSURE (B/P) AND OXYGEN SATURATION (SPO2). FOLLOWING THIS, THE PATIENT HAD A PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST AND WAS SUSPECTED OF PULMONARY EMBOLISM (PE). THE PATIENT WAS TREATED WITH A TISSUE PLASMINOGEN ACTIVATOR (TPA) DURING THE RESUSCITATION. HOWEVER, THE PATIENT DIED. PER THE REPORTER, IT IS UNKNOWN IF THE PATIENT DIED DUE TO PULMONARY EMBOLISM OR OTHER CAUSES OR IF THE CATHETER HAD ANY RELATION TO THE SUSPECTED PE. THE CUSTOMER PROVIDED NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278499 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 UNKNOWN 00849111075282

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death| O