ZOLL IVTM QUATTRO CATHETER
Report
- Report Number
- 3010617000-2024-00195
- Event Type
- Injury
- Date Received
- February 16, 2024
- Date of Event
- February 12, 2024
- Report Date
- February 16, 2024
- Manufacturer
- ZOLL CIRCULATION
- Product Code
- NCX
- UDI-DI
- 00849111075275
- PMA / PMN Number
- K101987
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE QUATTRO CATHETER ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER. THEREFORE, A PHYSICAL INVESTIGATION OF THE CATHETER COULD NOT BE PERFORMED. THE EVENT OF DVT WAS ASSESSED AS SERIOUS. EVENT OF DVT WAS ASSESSED AS SERIOUS BECAUSE BASED ON AVAILABLE INFORMATION, TREATMENT WAS REQUIRED. EVENT ASSESSED AS PROBABLY RELATED TO THE ZOLL CATHETER DUE TO RELEVANT TIMING AND LOCATION OF DVT. AT THE SAME TIME, THE PATIENT'S POST CARDIAC ARREST CONDITION AND IMMOBILITY 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). THE RATE OF DVT IN THE PATIENT POPULATION RECEIVING IVTM POST-CARDIAC ARREST IS 1.7%. 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 AN ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR WITH THE USAGE OF ANY CATHETER. THE EVENT IS PROBABLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.
A 57-YEAR-OLD FEMALE PATIENT WHO WEIGHED 95 KILOGRAMS EXPERIENCED CARDIAC ARREST AND RECEIVED IVTM THERAPY TO INDUCE CONTROLLED HYPOTHERMIA. THE QUATTRO CATHETER (LOT# UNKNOWN) WAS INSERTED SMOOTHLY ON THE FIRST ATTEMPT INTO THE FEMORAL RIGHT VEIN AND USED FOR THERAPY WITHOUT COMPLICATIONS. THE PATIENT'S INITIAL TEMPERATURE WAS 36 DEGREES CELSIUS. THE CATHETER FUNCTIONED AS INTENDED DURING THE FOUR DAYS OF TREATMENT. AFTER CATHETER REMOVAL, THE ULTRASOUND REVEALED THROMBOSIS IN THE INFERIOR VENA CAVA. THE PATIENT HAD NO PRIOR HIGH-RISK FACTORS FOR DEEP VEIN THROMBOSIS (DVT) AND NO PREVIOUS CENTRAL VENOUS CATHETER (CVC) PLACEMENT. COAGULOPATHY RESULTS BEFORE THERAPY INITIATION WERE NORMAL AND THE PATIENT RECEIVED 5,000 IU OF HEPARIN IN THE CARDIAC CATHETERIZATION LABORATORY. IN THE INTENSIVE CARE UNIT, THE PATIENT THEN RECEIVED HEPARIN AT 25,000 IU PER DAY, WITH DOSAGE ADJUSTMENTS MADE UPON THROMBOSIS DETECTION TO ACHIEVE A TARGET PARTIAL THROMBOPLASTIN TIME (PTT) RANGE OF 60-70 SECONDS. THE PATIENT IS CURRENTLY TRACHEOTOMIZED, VENTILATED, ALERT, AND RESPONSIVE, WITH EFFECTIVE ANTICOAGULATION BEING PURSUED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 510403 | ZOLL IVTM QUATTRO CATHETER | CENTRAL VENOUS CATHETER | NCX | ZOLL CIRCULATION | IC-4593AE | UNKNOWN | 00849111075275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | Other |