BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM CATHETER

    MDR report key: 14835174 · Received June 27, 2022

    Report

    Report Number
    3010617000-2022-00712
    Event Type
    Malfunction
    Date Received
    June 27, 2022
    Date of Event
    June 1, 2022
    Report Date
    September 14, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ZOLL CATHETER USED AT THE TIME OF THE EVENT WILL NOT BE RETURNED FOR EVALUATION. THEREFORE, A PHYSICAL INVESTIGATION OF THE CATHETER COULD NOT BE PERFORMED. EVENT OF DVT WAS ASSESSED AS NOT SERIOUS BECAUSE NO THE PATIENT'S CLINICAL SYMPTOMS OF DVT OR TREATMENT WERE REPORTED. EVENT ASSESSED AS POSSIBLY RELATED TO THE ZOLL CATHETER. AT THE SAME TIME, THE PATIENT'S CRITICAL CONDITION AND IMMOBILITY POSSIBLY CONTRIBUTED IN DEVELOPMENT OF CURRENT CONDITION OF DVT AS WELL. 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). 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; EVENT WAS NOT SERIOUS. THE REPORTED EVENT IS POSSIBLE RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

    Additional Manufacturer Narrative · 0

    NO CATHETER WAS RETURNED TO ZOLL FOR EVALUATION. THEREFORE, A PHYSICAL INVESTIGATION OF THE CATHETER COULD NOT BE PERFORMED. THE TRAINING PHYSICIAN WAS NOT ABLE TO PROVIDE ANY EVIDENCE OF DVT. THEREFORE, ANY INCIDENT(S) OF THE ALLEGED DVT(S) COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    THE CUSTOMER WAS PROVIDING TRAINING ON THE ZOLL COOL LINE AND ICY CATHETERS TO THEIR HEALTHCARE PROVIDERS. DURING THE TRAINING ON THESE PRODUCTS, WHICH THE CUSTOMER IS VERY FAMILIAR WITH, SOME RECOMMENDATIONS WERE MADE FOR IMPROVING ZOLL CATHETER KITS. THE FIRST SUGGESTION WAS THAT A SLIP TIP SYRINGE SHOULD BE PLACED WITHIN THE CATHETER KIT. AS PER THE CUSTOMER, THE LUER LOCK MAKES IT MORE DIFFICULT TO DISCONNECT AND PLACE THE GUIDEWIRE THROUGH. THE SCREW-ON TIP VERSUS THE STRAIGHT TIP MAKES DISCONNECTING FROM THE PATIENT MORE CHALLENGING, ONCE A VEIN IS FOUND, COMPARED TO HAVING A SLIP TIP SYRINGE. THE SECOND RECOMMENDATION WAS ON THE GUIDEWIRE. MOST GUIDEWIRES CAN BE PARTIALLY PULLED BACK OUT FROM THE COVER AND THE TIP WILL STRAIGHTEN. ON ZOLL GUIDEWIRES, THIS IS EXTREMELY HARD TO PERFORM. THE CUSTOMER ALSO STATED THAT SHE HEARD FROM OTHER MEDICAL PROFESSIONALS THAT ZOLL CATHETERS HAVE RESULTED IN DEEP VEIN THROMBOSIS (DVT) IN PATIENTS. THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION ON WHAT TYPE OF ZOLL CATHETER HAS CAUSED DVT OR DETAILS OF ANY INCIDENTS. AS PER THE CUSTOMER, THERE IS NO ZOLL CATHETER TO BE RETURNED, BUT UTILIZATION OF ZOLL CATHETERS IS LOW DUE TO THE PERCEPTION OF HEALTHCARE PROVIDERS THINKING THAT ZOLL CATHETERS CAUSE DVT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734521 ZOLL IVTM CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other