BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 8364666 · Received February 22, 2019

    Report

    Report Number
    3010617000-2019-00113
    Event Type
    Injury
    Date Received
    February 22, 2019
    Report Date
    February 22, 2019
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075275
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE QUATTRO CATHETER USED AT THE TIME OF THE EVENT WILL NOT BE RETURNED FOR EVALUATION, IT HAS BEEN LIKELY DISPOSED OF. THEREFORE, A PHYSICAL INVESTIGATION WILL NOT BE PERFORMED. EVENT OF DVT WAS ASSESSED AS NOT SERIOUS BECAUSE BASED ON AVAILABLE INFORMATION, THE PATIENT DID NOT EXPERIENCE ANY CLINICAL SYMPTOMS OF DVT, AND IT WAS A FINDING WITH CATHETER REMOVAL. NO KNOWN IMPACT OR PATIENT CONSEQUENCE INFORMATION WAS AVAILABLE. EVENT ASSESSED AS POSSIBLY RELATED TO THE QUATTRO CATHETER DUE TO RELEVANT TIMING AND LOCATION OF DVT. 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. DATE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMALE PATIENT WAS INSERTED A QUATTRO CATHETER WITHOUT ISSUE IN THE FEMORAL VEIN FOR AN IVTM TREATMENT OF HYPOTHERMIA AFTER CPR. FOUR DAYS AFTER THE IVTM THERAPY WAS COMPLETED AND DURING THE CATHETER REMOVAL THE DEEP VEIN THROMBOSIS (DVT) WAS DISCOVERED. NO ADDITIONAL INFORMATION PROVIDED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE INFORMATION WAS AVAILABLE. THE QUATTRO CATHETER WAS DISPOSED OF BY THE CUSTOMER AND NOT RETURNING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157133 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 UNKNOWN 00849111075275

    Patients

    Seq Age Sex Outcome Treatment
    1 Other