BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM CATHETER

    MDR report key: 12218911 · Received July 23, 2021

    Report

    Report Number
    3010617000-2021-00687
    Event Type
    Injury
    Date Received
    July 23, 2021
    Report Date
    July 23, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ZOLL CATHETER WAS NOT RETURNED. THEREFORE, PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. ONE PARTICIPANT IN THE NORMOTHERMIA GROUP HAD REGAINED CONSCIOUSNESS AND COMPLAINED OF PAIN IN THE LOWER LEG. A DEEP VENOUS THROMBOSIS WAS SUSPECTED, AND AN ULTRASOUND WAS REQUESTED. BEFORE THE SCAN WAS PERFORMED THE INTRAVASCULAR COOLING DEVICE WAS REMOVED. FOLLOWING REMOVAL, THE PARTICIPANT HAD A CARDIAC ARREST (WITH INITIAL PULSELESS ELECTRIC ACTIVITY (PEA)). THE PARTICIPANT WAS SUCCESSFULLY RESUSCITATED BUT DETERIORATED AND DIED DUE TO HEMODYNAMIC FAILURE AFTER 24 HOURS. A BEDSIDE ECHOCARDIOGRAM SHOWED A DILATED RIGHT VENTRICLE. A PULMONARY EMBOLISM FROM A DEVICE-RELATED CLOT WITH WAS CONSIDERED THE PROBABLE CAUSE. EVENT OF DVT WAS ASSESSED AS SERIOUS AND POSSIBLY RELATED TO COOLING DEVICE BECAUSE BASED ON AVAILABLE INFORMATION. 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). 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. 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].

    Description of Event or Problem · 1

    IN "THE NEW ENGLAND JOURNAL OF MEDICINE ARTICLE - HYPOTHERMIA VERSUS NORMOTHERMIA AFTER OUT-OF-HOSPITAL CARDIAC ARREST," FOUR PATIENTS IN THE TARGETED TEMPERATURE MANAGEMENT (TTM) GROUP PRESENTED AN ADVERSE EVENT. IN AN OPEN-LABEL TRIAL WITH BLINDED ASSESSMENT OF OUTCOMES, RANDOMLY ASSIGNED PATIENTS WITH COMA WHO HAD AN OUT-OF-HOSPITAL CARDIAC ARREST OF PRESUMED CARDIAC OR UNKNOWN CAUSE UNDERGO TARGETED HYPOTHERMIA AT 33°C, FOLLOWED BY CONTROLLED REWARMING OR TARGETED NORMOTHERMIA WITH EARLY TREATMENT OF FEVER (BODY TEMPERATURE, GREATER THAN OR EQUAL TO 37.8°C). TWO UNEXPECTED SERIOUS, POSSIBLY INTERVENTION-RELATED ADVERSE EVENTS OCCURRED IN EACH GROUP: AN INTRAVASCULAR DEVICE-RELATED THROMBOSIS IN ONE PATIENT IN THE HYPOTHERMIA GROUP, TWO PATIENTS IN THE NORMOTHERMIA GROUP, AND BRADYCARDIA WITH WORSENING HEMODYNAMIC FUNCTION IN ONE PATIENT IN THE HYPOTHERMIA GROUP. THIS CCR IS FOR PATIENT #1, ONE PARTICIPANT IN THE NORMOTHERMIA GROUP HAD REGAINED CONSCIOUSNESS AND COMPLAINED OF PAIN IN THE LOWER LEG. A DEEP VENOUS THROMBOSIS WAS SUSPECTED, AND AN ULTRASOUND WAS REQUESTED. BEFORE THE SCAN WAS PERFORMED THE INTRAVASCULAR COOLING DEVICE WAS REMOVED. FOLLOWING REMOVAL, THE PARTICIPANT HAD A CARDIAC ARREST (WITH INITIAL PULSELESS ELECTRIC ACTIVITY (PEA)). THE PARTICIPANT WAS SUCCESSFULLY RESUSCITATED BUT DETERIORATED AND DIED DUE TO HEMODYNAMIC FAILURE AFTER 24 HOURS. A BEDSIDE ECHOCARDIOGRAM SHOWED A DILATED RIGHT VENTRICLE. A PULMONARY EMBOLISM FROM A DEVICE-RELATED CLOT WAS CONSIDERED THE PROBABLE CAUSE. AN IVTM CATHETER WAS USED, BUT THE MODEL OF THE CATHETER WAS NOT SPECIFIED. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2021- 00678 FOR THE PATIENT 2 OF 4. MFR # 3010617000-2021- 00677 FOR THE PATIENT 3 OF 4. MFR # 3010617000-2021- 00706 FOR THE PATIENT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113729 ZOLL IVTM CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O