BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 11972318 · Received June 10, 2021

    Report

    Report Number
    3010617000-2021-00494
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    May 14, 2021
    Report Date
    August 26, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075282
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED QUATTRO CATHETER (LOT # 153696) WAS RETURNED TO ZOLL FOR INVESTIGATION. NO MALFUNCTION OR LEAK WAS OBSERVED DURING TESTING, AND THE CATHETER FUNCTIONED AS INTENDED. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. DRIED BLOOD RESIDUE WAS OBSERVED ON THE BALLOONS AND ON THE LUERED TUBINGS, WHICH IS A NORMAL OBSERVATION FOR THE CATHETERS USED FOR PATIENT TREATMENT. THE BALLOONS WERE EXAMINED AND THERE WERE NO TEARS, BALLOON BOND DETACHMENT, OR RUPTURE. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI, AND NO ISSUE WAS NOTED. NO LEAK WAS OBSERVED DURING INFLATION AND DEFLATION OF THE BALLOONS. ALL LUMENS WERE FLUSHED AS INTENDED. EVENT OF DVT WAS ASSESSED AS SERIOUS BECAUSE THE PATIENT EXPERIENCES CLINICAL SYMPTOMS OF DVT AND TREATMENT WAS PROVIDED TO PREVENT PERMANENT INJURY. EVENT ASSESSED AS PROBABLY RELATED TO THE ZOLL CATHETER DUE TO CONFIRMED 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 [ZOLL WHITE PAPER ON DVT]. DVT IS ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR WITH USAGE OF ANY CATHETER.

    Description of Event or Problem · 0

    A 51-YEAR-OLD, MALE PATIENT WAS ADMITTED FOR A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) PROCEDURE AND RECEIVED TREATMENT WITH IVTM FOR FEVER CONTROL. THE PATIENT'S INITIAL BODY TEMPERATURE WAS AT 41°C. A QUATTRO CATHETER (LOT # 153696) WAS SMOOTHLY PLACED IN THE PATIENT'S LEFT FEMORAL VEIN WITH NO COMPLICATIONS. WITHIN 3 HOURS OF INSERTING THE CATHETER, THE PATIENT'S TEMPERATURE DECREASED TO BELOW 38 °C. THE PATIENT HAD RECEIVED VTE PROPHYLAXIS WITH SEQUENTIAL COMPRESSION DEVICE (SCD) HOSES AND MEDICATIONS (HEPARIN SUBQ Q8H). WITHIN 24 HOURS OF INITIATION OF THE TREATMENT, IT WAS NOTED THAT THE PATIENT DEVELOPED A DEEP VEIN THROMBOSIS (DVT) IN THE LEG WHERE THE CATHETER WAS INSERTED. THE PATIENT EXPERIENCED MOTTLING OF THE LEG, WHERE THE LEG WAS "PALE" AND "COOL TO TOUCH" WITH PEDAL PULSES. URGENT ULTRASOUND WAS ORDERED TO IDENTIFY THE CAUSE, AND A BLOOD CLOT WAS IDENTIFIED FROM GROIN TO ANKLE. IT IS NOT KNOWN WHETHER THE PATIENT HAD A PREVIOUS HISTORY OF DVT. THERE WAS NO REPORTED VASCULAR INJURY CAUSED BY THE CATHETER. THE PATIENT RECEIVED A DVT TREATMENT WITH HEPARIN DRIP AFTER THE DVT WAS DIAGNOSED. THE CATHETER WAS REMOVED EASILY, AND IT WAS REPLACED BY A LIKE UNIT. BLANKETS WERE USED AS AN ADJUNCT PROCEDURE TO COOL THE PATIENT AND COMPLETE THE TREATMENT. THE CURRENT CONDITION OF THE PATIENT IS STABLE. AS PER THE CUSTOMER, DVT WAS RELATED TO THE ZOLL CATHETER.

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE QUATTRO CATHETER IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED. EVENT OF DVT WAS ASSESSED AS SERIOUS BECAUSE THE PATIENT EXPERIENCED CLINICAL SYMPTOMS OF DVT AND TREATMENT WAS PROVIDED TO PREVENT PERMANENT INJURY. EVENT ASSESSED AS PROBABLY RELATED TO THE ZOLL CATHETER DUE TO CONFIRMED RELEVANT TIMING AND LOCATION OF DVT. DVT IS A KNOWN COMPLICATION OF CENTRAL CATHETERS OF ANY KIND. PATIENTS IN CRITICAL CONDITION ARE TREATED WITH IVTM. IN SUCH CASES, THOSE CONDITIONS MAKE THE PATIENTS PREDISPOSED TO THROMBOGENICITY. DEVELOPMENT OF THROMBUS IS A COMMON COMPLICATION IN SUCH PATIENT POPULATIONS. 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

    A (B)(6)-YEAR-OLD, MALE PATIENT WAS ADMITTED FOR A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) PROCEDURE AND RECEIVED TREATMENT WITH IVTM FOR FEVER CONTROL. PATIENT'S INITIAL BODY TEMPERATURE WAS AT 41°C. A QUATTRO CATHETER (LOT # UNKNOWN) WAS PLACED IN THE PATIENT'S LEFT FEMORAL VEIN SMOOTHLY WITH NO COMPLICATIONS. WITHIN 3 HOURS OF INSERTING THE CATHETER, THE PATIENT'S TEMPERATURE DECREASED TO BELOW 38 °C. THE PATIENT HAD RECEIVED VTE (VENOUS THROMBOEMBOLISM) PROPHYLAXIS WITH SEQUENTIAL COMPRESSION DEVICE (SCD) HOSES AND MEDICATIONS (HEPARIN SUBQ Q8H). WITHIN 24 HOURS OF INITIATION OF THE TREATMENT, IT WAS NOTED THAT THE PATIENT DEVELOPED A DEEP VEIN THROMBOSIS (DVT) IN THE LEG WHERE THE CATHETER WAS INSERTED. THE PATIENT EXPERIENCED MOTTLING OF THE LEG, WHERE THE LEG WAS "PALE" AND "COOL TO TOUCH" WITH PEDAL PULSES. URGENT ULTRASOUND WAS ORDERED TO IDENTIFY THE CAUSE, AND A BLOOD CLOT WAS IDENTIFIED FROM GROIN TO ANKLE. IT IS NOT KNOWN WHETHER THE PATIENT HAD A PREVIOUS HISTORY OF DVT. THERE WAS NO REPORTED VASCULAR INJURY CAUSED BY THE CATHETER. THE PATIENT RECEIVED A DVT TREATMENT WITH HEPARIN DRIP AFTER THE DVT WAS DIAGNOSED. THE CATHETER WAS REMOVED EASILY, AND IT WAS REPLACED BY A LIKE UNIT. BLANKETS WERE USED AS AN ADJUNCT PROCEDURE TO COOL THE PATIENT AND COMPLETE THE TREATMENT. THE CURRENT CONDITION OF THE PATIENT IS STABLE. AS PER THE CUSTOMER, DVT WAS RELATED TO THE ZOLL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875495 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 153696 00849111075282

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other