BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 8646407 · Received May 28, 2019

    Report

    Report Number
    3010617000-2019-00431
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    May 2, 2019
    Report Date
    May 28, 2019
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075282
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE PRODUCT FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED. PER MEDICAL SAFETY ASSESSEMENT, EVENT OF DVT WAS ASSESSED AS SERIOUS BECAUSE BASED ON AVAILABLE INFORMATION, THE PATIENT EXPERIENCE CLINICAL SYMPTOMS OF DVT. NO KNOWN ADVERSE HEALTH IMPACT TO THE PATIENT. EVENT ASSESSED AS POSSIBLY RELATED TO THE QUATTRO CATHETER DUE TO RELEVANT TIMING AND LOCATION OF DVT. AT THE SAME TIME, THE PATIENT'S EXTENSIVE HISTORY OF PERIPHERAL VASCULAR DISEASE POSSIBLY CONTRIBUTED IN DEVELOPMENT OF CURRENT CONDITION 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 [ZOLL WHITE PAPER ON DVT].

    Description of Event or Problem · 1

    INTRAVASCULAR TEMPERATURE MANAGEMENT (IVTM) COOLING THERAPY OF A (B)(6) MALE WAS SUSPENDED AFTER THE PHYSICIAN OBSERVED THAT THE PATIENT DEVELOPED A COLD PULSELESS RIGHT FOOT. THE CUSTOMER REPORTED THAT THE QUATTRO CATHETER (LOT #UNKNOWN) WAS PLACED IN THE PATIENT'S RIGHT FEMORAL VEIN FOR 20 HOURS OF DWELL TIME, WHEN THE EVENT WAS OBSERVED. ACCORDING TO THE REGISTERED NURSE, THE PATIENT HAD A HISTORY OF PERIPHERAL VASCULAR DISEASE, BILATERAL KNEE REPLACEMENT AND SMOKING. THE PATIENT HAD A HISTORY OF WEAK PULSES. THE IVTM THERAPY WAS DISCONTINUED. HOWEVER; CUSTOMER CONTINUED USING THE TRIPLE LUMEN AND CONTINUED THERAPY WITH SURFACE COOLING TREATMENT. THE PHYSICIAN ORDERED AN ULTRASOUND OF THE PATIENT'S LOWER EXTREMITY TO DIAGNOSE DVT AND THE PATIENT WAS ALREADY ON A HEPARIN DRIP PROPHYLACTICALLY, NO ADDITIONAL MEDICATIONS OR TREATMENTS WERE INSTITUTED. NO KNOWN ADVERSE HEALTH IMPACT TO THE PATIENT. NO DEVICE MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438422 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 UNKNOWN 00849111075282

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other