BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 12292041 · Received August 6, 2021

    Report

    Report Number
    3010617000-2021-00716
    Event Type
    Injury
    Date Received
    August 6, 2021
    Date of Event
    June 13, 2021
    Report Date
    August 6, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075282
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE QUATTRO CATHETER USED AT THE TIME OF THE EVENT WILL NOT BE RETURNED FOR EVALUATION, AS IT WAS DISCARDED BY THE CUSTOMER. 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 PULMONARYEMBOLISM 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 WERE 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, EMBOLI IN VEIN SYSTEM WAS NOT RELATED TO ZOLL CATHETER, WHICH DID NOT MALFUNCTION. MORE LIKELY EMBOLI WERE RELATED TO THE PATIENT'S CLINICAL CONDITION OF SEVERAL TRAUMATIC INJURIES (SPINAL AND FEM FRACTURE). ZOLL R&D CONFIRMED THAT: IF THE QUATTRO WAS PLACED FEMORALLY AS DESCRIBED, AIR EMBOLI OBSERVED IN THE BRACHIOCEPHALIC/SVC APPEARS TO BE ENTIRELY UNRELATED. THERE IS NO WAY FOR AIR TO GET THERE FROM THE IVC. EVENT WAS SERIOUS DUE TO OUTCOME DEATH. EVENT NOT RELATED TO ZOLL CATHETER.

    Description of Event or Problem · 1

    THE (B)(6) MALE PATIENT WAS HOSPITALIZED POST-CARDIAC ARREST WITH PULSELESS ELECTRICAL ACTIVITY (PEA) AND UNDERWENT IVTM THERAPY. THE PATIENT ARRIVED IN THE EMERGENCY DEPARTMENT AT 1:30 PM AND THE QUATTRO CATHETER WAS INSERTED INTO THE FEMORAL VEIN SUCCESSFULLY IN A SINGLE ATTEMPT. IN ADDITION, THE ARTERIAL LINE WAS PLACED WITHIN 20 MIN OF ARRIVAL. PER THE REPORTER, IT IS UNKNOWN HOW MANY ATTEMPTS WERE MADE FOR THE ARTERIAL LINE PLACEMENT. AT 5:30 PM CHEST CT WAS PERFORMED AND NOTED TO HAVE MULTIFOCAL AIR EMBOLI IN THE LEFT UPPER EXTREMITY VENOUS VASCULATURE, EXTENDING INTO THE RIGHT BRACHIOCEPHALIC VEIN, SUPERIOR VENA CAVA (SVC), AND RIGHT VENTRICLE, WITH PUNCTATE AIR EMBOLI IN THE MAIN PULMONARY ARTERY AND RIGHT PULMONARY ARTERY. PER THE REPORTER, THE SOURCE OF AIR IS UNKNOWN. THE PATIENT EXPIRED 5 DAYS LATER AFTER THE TRANSITION TO COMFORT CARE. THE PATIENT HAD A HISTORY OF EXCESSIVE DRINKING, EMACIATED, SEVERAL TRAUMATIC INJURIES (SPINAL AND FEM FRACTURE), GI BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185990 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 UNKNOWN 00849111075282

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| O