BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 3841888 · Received May 30, 2014

    Report

    Report Number
    3003793491-2014-00263
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PHYSICIAN FOUND A THROMBUS AT THE DISTAL TIP OF THE CATHETER. PER LABELING, POSSIBLE COMPLICATIONS WITH CENTRAL VENOUS CATHETERS INCLUDE THROMBOSIS. HOWEVER, PATIENT WAS A DRUG ABUSER, SMOKER AND WAS IN A HIGH RISK CATEGORY FOR DVT. THE LABELING ALSO INDICATES THAT THE MAXIMUM USER PERIOD FOR THE ZOLL QUATTRO CATHETER IS 4 DAYS. HOWEVER, THE CATHETER WAS KEPT IN THE PATIENT FOR 5 DAYS. IN ADDITION, THE PATIENT WAS GIVEN PLATELET THERAPY (EXACT AMOUNT OF PLATELETS WAS NOT PROVIDED). PLEASE NOTE THAT PLATELETS HELP WITH BLOOD CLOTTING. FURTHERMORE, THERE WERE NO REPORTS OF ANY ISSUES OR DEVICE MALFUNCTIONS RELATED TO THE ZOLL QUATTRO CATHETER. PRODUCT IN COMPLAINT WILL NOT BE RETURNED. THEREFORE, PHYSICAL INVESTIGATION CANNOT BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE FILED IF THE PRODUCT IN COMPLAINT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    A (B)(6) OLD FEMALE PATIENT CAME INTO THE HOSPITAL ON (B)(6) 2014 FOR A HEROIN OVERDOSE AND WAS DISCHARGED AFTER RECEIVING NARCAN. WITH AN UNKNOWN DOWN TIME, SHE WAS LATER FOUND UNRESPONSIVE BY A FAMILY MEMBER. THE PATIENT EXPERIENCED CHEST PAIN AND THEN SUBSEQUENTLY PASSED OUT. THE FAMILY MEMBER CALLED EMS AND INITIATED CPR. EMS FOUND THE PATIENT ASYSTOLIC AND IN CARDIAC ARREST. CPR WAS CONTINUED AND DEFIBRILLATION WAS ATTEMPTED. PATIENT WAS GIVEN TWO ROUNDS OF EPINEPHRINE AND 2 ROUNDS OF NARCAN. RETURN OF SPONTANEOUS CIRCULATION (ROSC) SINUS TACHYCARDIA WAS ACHIEVED. DOPAMINE WAS INITIATED IN THE FIELD AND PATIENT WAS TRANSFERRED TO THE HOSPITAL. PATIENT WAS TREATED WITH ICE PACKS AND THEN TRANSFERRED TO A SECOND HOSPITAL (HOSPITAL OF CENTRAL CONNECTICUT) FOR THERAPEUTIC HYPOTHERMIA. DOPAMINE WAS DISCONTINUED AT THIS HOSPITAL DUE TO HEMODYNAMIC STABILITY. IN THE EMERGENCY DEPARTMENT OF THE HOSPITAL OF (B)(6), THE PATIENT RECEIVED FURTHER CARE AND WAS TRANSFERRED TO THE CATHETERIZATION LAB. IN CARDIAC CATHETERIZATION LAB, THE PATIENT WAS FOUND TO HAVE AN OCCLUDED DIAGONAL BRANCH WHICH WAS SUCCESSFULLY RE-VASCULARIZED. AT THE SAME TIME, THE PATIENT WAS INITIATED WITH THERAPEUTIC HYPOTHERMIA USING A ZOLL QUATTRO CATHETER. PATIENT WAS NOT HEPARINIZED PRIOR TO THE START OF THERAPY. THERE WERE NO OTHER TEMPERATURE MANAGEMENT PROCEDURES PERFORMED ON THE PATIENT PRIOR TO COOLING. PRIOR TO THERAPY, CT SCAN RESULTS "LOOKED POOR" (RESULTS WERE NOT PROVIDED). THERE WAS NO EVIDENCE OF ANY CLOT FORMATION. INITIAL CBC WAS PERFORMED BUT THE RESULTS WERE NOT PROVIDED. IT IS ALSO UNKNOWN IF BLOOD COAGULOPATHY TESTS WERE PERFORMED. A ZOLL QUATTRO CATHETER WAS INSERTED INTO THE LEFT FEMORAL VEIN BY A RESIDENT PHYSICIAN VIA ULTRASOUND GUIDED IMAGERY. THIS WAS THE RESIDENT'S FIRST TIME INSERTING THE ZOLL CATHETER WITH GUIDANCE FROM AN ADVANCED PRACTICE REGISTERED NURSE (APRN) AND ZOLL CLINICAL PERSONNEL. INSERTION WAS SMOOTH AND WAS MADE IN ONE ATTEMPT. THERE WAS NO OTHER CENTRAL VENOUS CATHETER (CVC) PLACEMENT PRIOR TO OR AFTER THE ZOLL CATHETER INSERTION. THE PATIENT'S TEMPERATURE AT THE START OF THERAPY WAS 34.2 DEGREES C AS MEASURED BY A FOLEY CATHETER PROBE. AN ESOPHAGEAL PROBE WAS INSERTED AND SHOWED A 0.5 DEGREES C LOWER CORE BODY TEMPERATURE. THE QUATTRO CATHETER WAS ATTACHED TO THE THERMOGARD CONSOLE. THE PATIENT WAS COOLED TO TARGET TEMPERATURE OF 33 DEGREES C IN 15 MINUTES. THE TEMPERATURE PROBE SLAVED INTO THE THERMOGARD CONSOLE WAS SWITCHED FROM THE FOLEY TO THE ESOPHAGEAL PROBE FOR ACCURACY. THE TOTAL TIME FROM HOSPITAL ADMISSION TO THE START OF HYPOTHERMIA THERAPY WAS 45 MINUTES. ON THE 4TH DAY, THE PATIENT WAS TAKEN TO MRI AND THE NURSING STAFF STATED THAT THE TEST SHOWED SEVERE ANOXIC ENCEPHALOPATHY. NO ADDITIONAL MRI RESULTS WERE PROVIDED. ZOLL CLINICAL PERSONNEL ADVISED THE NURSING STAFF THAT THE CATHETER NEEDED TO BE REMOVED AND EXPLAINED THE RISKS INVOLVED. SINCE THE STAFF BELIEVED THAT THE PATIENT HAD NO CHANCE OF SURVIVAL, THEY OPTED NOT TO FOLLOW THE ADVICE. THE STAFF DID NOT BELIEVE THAT IT WAS URGENT TO TERMINATE THERAPY AT THE TIME. THE THERMOGARD WAS PUT ON STANDBY WHILE THE PATIENT WAS IN FOR THE MRI. AFTER THE MRI, THE STAFF STARTED TO REWARM THE PATIENT TO 37 DEGREES C. AFTER REWARMING, PATIENT DEVELOPED DISSEMINATED INTRAVASCULAR COAGULATION (DIC) AND WAS GIVEN PLATELETS. IT IS UNKNOWN HOW MUCH PLATELETS WERE GIVEN TO THE PATIENT. ALTHOUGH THE HOSPITAL'S POLICY IS TO REMOVE THE CATHETER IN 72 HOURS, THE ZOLL CATHETER WAS LEFT IN THE PATIENT FOR 5 DAYS. AFTER 5 DAYS, THE THERAPY WAS DISCONTINUED. THE PATIENT WAS ALSO DIAGNOSED WITH ANOXIC BRAIN INJURY AND THE NURSE STAFF BELIEVED THAT THE PATIENT WAS BRAIN DEAD. THE PATIENT'S FAMILY WAS LOOKING TO DONATE HER ORGANS. HOWEVER, IT WAS DETERMINED THAT THE PATIENT WAS NOT BRAIN DEAD YET, SO THE FAMILY REQUIRED ADDITIONAL TIME TO MAKE A DECISION. ON DAY 5, ORGAN HARVESTING BEGAN AND THE PHYSICIAN FOUND A THROMBUS AT THE DISTAL TIP OF THE CATHETER. NO VESSEL RUPTURE WAS REPORTED. AS A RESULT OF THE OBSERVED THROMBUS, PATIENT WAS ELIMINATED AS A CANDIDATE FOR ORGAN DONATION. PATIENT WAS NOT ON ANY DVT PROPHYLAXIS. HOWEVER, PATIENT WAS IN A HIGH RISK CATEGORY FOR DVT DUE TO DRUG ABUSE. PATIENT WAS ALSO A SMOKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319140 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION, INC 8700-0660-01

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other ICE PACKS| NARCAN, EPINEPHRINE, DOPAMINE