BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 11363904 · Received February 23, 2021

    Report

    Report Number
    3010617000-2021-00173
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 5, 2021
    Report Date
    March 17, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075251
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT ASSESSED AS NOT SERIOUS. DVT WAS AN ACCIDENTAL FINDING DURING SONOGRAPHY. BASED ON AVAILABLE INFORMATION, THE PATIENT DID NOT EXPERIENCE CLINICAL SYMPTOMS OF DVT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE ICY CATHETER WILL NOT BE RETURNED TO ZOLL FOR INVESTIGATION, AS IT WAS DISPOSED BY THE CUSTOMER. THEREFORE, A PHYSICAL INVESTIGATION WILL NOT BE PERFORMED. PER ZOLL MEDICAL SAFETY ASSESSMENT, THE EVENT OF DVT WAS ASSESSED AS NOT SERIOUS AS BASED ON AVAILABLE INFORMATION, THE PATIENT DID NOT EXPERIENCE CLINICAL SYMPTOMS OF DVT. NO PATIENT CONSEQUENCE WAS REPORTED. THE EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE ZOLL CATHETER DUE TO RELEVANT TIMING AND LOCATION OF DVT. AT THE SAME TIME, THE PATIENT'S CLINICAL CONDITION OF CARDIAC ARREST AND IMMOBILITY INCREASED RISK 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 IN 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). 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) YEARS OLD FEMALE PATIENT WAS TREATED FOR HYPOTHERMIA AFTER CARDIAC ARREST. IT WAS NOTED THAT THE ICY CATHETER (LOT# UNKNOWN) WAS PLACED SMOOTHLY IN THE PATIENT'S LEFT FEMORAL VEIN BY AN EXPERIENCED PHYSICIAN IN A SINGLE ATTEMPT. AFTER 96 HOURS OF IVTM THERAPY, WHEN THE PATIENT REACHED THE TARGET TEMPERATURE OF 36,5¿C WITH THE REWARMING RATE OF 0,1¿C, THE ICY CATHETER WAS REMOVED. DURING SONOGRAPHIC RANDOM FINDING WITHOUT FULMINANT SYMPTOMS, THE PHYSICIAN DIAGNOSED A 1.5-2 CM LONG THROMBOSIS WITHIN THE VENA CAVA. THERE WAS NO THROMBOGENIC MATERIAL OBSERVED ON THE ICY CATHETER AFTER REMOVAL. THE PATIENT HAD A HISTORY OF IMMOBILITY. THE DOCTOR CLAIMED THAT CENTRAL VENOUS CATHETER (CVC) ARTERIAL BLOOD PRESSURE MEASUREMENT PLACEMENT WAS PERFORMED PRIOR TO THE ICY CATHETER. THE PATIENT WAS PROVIDED WITH ASPIRIN, CLOPIDOGREL, AND LOW MOLECULAR WEIGHT HEPARIN AS ANTITHROMBOSIS PROPHYLAXIS. THE ADJUSTMENTS WERE MADE TO THE PATIENT'S ANTICOAGULANT MEDICATION AND CONSERVATIVE TREATMENT OF THROMBOSIS WAS INITIATED. PER THE REPORTER, THE PATIENT WAS FULLY HEPARINIZED AND HAS BEEN IN REHABILITATION. NO PATIENT CONSEQUENCE WAS REPORTED. THE ICY CATHETER WAS DISPOSED BY THE CUSTOMER AND WILL NOT BE RETURNED TO ZOLL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261153 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893AE UNKNOWN 00849111075251

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other