BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 5173455 · Received October 24, 2015

    Report

    Report Number
    3010617000-2015-00576
    Event Type
    Malfunction
    Date Received
    October 24, 2015
    Date of Event
    November 25, 2015
    Report Date
    February 1, 2017
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075114
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THERE WERE NO DEVICE DEFICIENCIES REPORTED BY THE SITE, THE DEVICE ASSOCIATED WITH THIS COMPLAINT WILL NOT BE RETURNED TO ZOLL FOR PHYSICAL EVALUATION. BASED ON THE INFORMATION PROVIDED BY THE SITE, THERE WERE NO DEVICE DEFICIENCIES REPORTED. THIS POST CARDIAC ARREST PATIENT, WHO WAS INTUBATED, EXPERIENCED SEVERAL EVENTS DURING HIS HOSPITAL STAY. DURING NORMOTHERMIA PHASE OF COOLING PROCEDURE, THE PATIENT EXPERIENCED SYMPTOMS OF URINARY TRACT INFECTION. THE PATIENT RECEIVED TREATMENT WITH MEDICATIONS. THE SITE REPORTED THAT THIS EVENT WAS NOT SERIOUS, RELATED TO THE PATIENT'S CLINICAL CONDITION, NOT RELATED TO THE STUDY DEVICE OR STUDY PROCEDURE. THE PATIENT SHOWED SYMPTOMS OF PNEUMONIA. THE PATIENT WAS INTUBATED FOR 2 DAYS AT THE TIME OF THE EVENT. THE SITE REPORTED THAT THE AE WAS RELATED TO THE PATIENT'S CLINICAL CONDITION, AND NOT RELATED TO THE STUDY DEVICE OR STUDY PROCEDURE (AT ADMISSION ON (B)(6) 2015, X-RAY ALREADY HAD REVEALED A POSSIBLE PNEUMONIA DUE TO ASPIRATION). [VENTILATOR-ASSOCIATED PNEUMONIA IS A KNOWN COMPLICATION DURING HOSPITAL STAY, ESPECIALLY IN IMMOBILIZE INTUBATED PATIENTS. RECENT DATA ANALYSIS OF 20 TRIALS, WHICH ENROLLED 1885 PATIENTS, SUPPORTS THE CONCLUSION THAT TM DOES NOT INCREASE RATE OF PNEUMONIA DURING HOSPITAL STAY (1). (1. CROSSLEY S, REID J, MCLATCHIE R, HAYTON J, CLARK C, MACDOUGALL M, ANDREWS PJ. A SYSTEMATIC REVIEW OF THERAPEUTIC HYPOTHERMIA FOR ADULT PATIENTS FOLLOWING TRAUMATIC BRAIN INJURY.CRIT CARE. 2014 APR 17;18(2):R75. GEORGIOU AP1, MANARA AR. ROLE OF THERAPEUTIC HYPOTHERMIA IN IMPROVING OUTCOME AFTER TRAUMATIC BRAIN INJURY: A SYSTEMATIC REVIEW. BR J ANAESTH. 2013 MAR;110(3):357-67). A LITERATURE REVIEW LED TO A CONCLUSION THAT TH DID NOT INCREASE PNEUMONIA RATES IN (B)(6) PATIENTS. A SYSTEMATIC REVIEW OF ADVERSE EVENTS IN PATIENTS UNDERGOING THERAPEUTIC HYPOTHERMIA AFTER CARDIAC ARREST DEMONSTRATED THAT TH WAS ASSOCIATED WITH REDUCED IN-HOSPITAL MORTALITY, MORTALITY AT 1 MONTH, AND MORTALITY AT 6 MONTHS. THERE IS A TREND OF A HIGHER RATE OF PNEUMONIA IN THE HYPOTHERMIA GROUPS THAN IN THE NORMOTHERMIA GROUPS (RR, 1.18, 95% CI, 0.99 TO 1.40, P=0.06; I2=30%). HOWEVER, THE TREND WAS ONLY OBSERVED IN EARLIER TRIALS (BEFORE 2006) AND WAS NOT CONFIRMED IN LATER TRIALS (AFTER 2006). THIS MAY BE DUE TO THE ADVANCEMENT IN GENERAL (B)(6) POST-HOSPITAL MANAGEMENT WITH TIME, AN EVOLVING TH PROTOCOL AS THE TECHNOLOGY WAS DEVELOPED AND IMPROVED, AND/OR BETTER TRIAL DESIGNS TO REDUCE BIAS IN THE LATER TRIALS (2). IN THE RECENT TARGETED TEMPERATURE MANAGEMENT AT 33°C VERSUS 36°C AFTER CARDIAC ARREST TRIAL (TTM), NO DIFFERENCE WAS OBSERVED FOR THE RATES OF PNEUMONIA AT TWO DIFFERENT TARGET TEMPERATURES (52% VS. 46%, P=0.089) IN UNCONSCIOUS SURVIVORS OF OUT-OF-HOSPITAL CARDIAC ARREST OF PRESUMED CARDIAC CAUSE (3). (2. XIAO G, GUO Q, SHU M, XIE X, DENG J, ZHU Y, WAN C. SAFETY PROFILE AND OUTCOME OF MILD THERAPEUTIC HYPOTHERMIA IN PATIENTS FOLLOWING CARDIAC ARREST: SYSTEMATIC REVIEW AND META-ANALYSIS. EMERG MED J. 2013 FEB;30(2):91-100. 3. NIELSEN N, WETTERSLEV J, CRONBERG T, ERLINGE D, GASCHE Y, HASSAGER C, HORN J, HOVDENES J, KJAERGAARD J, KUIPER M, PELLIS T, STAMMET P, WANSCHER M, WISE MP, ÅNEMAN A, AL-SUBAIE N, BOESGAARD S, BRO-JEPPESEN J, BRUNETTI I, BUGGE JF, HINGSTON CD, JUFFERMANS NP, KOOPMANS M, KØBER L, LANGØRGEN J, LILJA G, MØLLER JE, RUNDGREN M, RYLANDER C, SMID O, WERER C, WINKEL P, FRIBERG H; TTM TRIAL INVESTIGATORS. TARGETED TEMPERATURE MANAGEMENT AT 33°C VERSUS 36°C AFTER CARDIAC ARREST. N ENGL J MED. 2013 DEC 5;369(23):2197-206). LITERATURE SEARCH ALSO SHOWED THAT PNEUMONIA DID NOT IMPACT MORTALITY AND NEUROLOGICAL OUTCOME IN (B)(6) PATIENT. EARLY-ONSET PNEUMONIA IS A COMMON COMPLICATION AFTER SUCCESSFUL CARDIOPULMONARY RESUSCITATION REGARDLESS OF HYPOTHERMIA TREATMENT. THE ONSET OF PNEUMONIA MAY INCREASE THE LENGTH OF MECHANICAL VENTILATION DURATION AND INTENSIVE CARE UNIT STAY, BUT ITS INFLUENCE ON SURVIVAL AND NEUROLOGICAL OUTCOME IS MARGINAL15, 16. PROPHYLACTIC ANTIBIOTICS WERE ASSOCIATED WITH A REDUCED INCIDENCE OF PNEUMONIA BUT A SIMILAR RATE OF GOOD FUNCTIONAL OUTCOME (4). (4. GAGNON DJ, NIELSEN N, FRASER GL, RIKER RR, DZIODZIO J, SUNDE K, HOVDENES J, STAMMET P, FRIBERG H, RUBERTSSON S, WANSCHER M, SEDER DB. PROPHYLACTIC ANTIBIOTICS ARE ASSOCIATED WITH A LOWER INCIDENCE OF PNEUMONIA IN CARDIAC ARREST SURVIVORS TREATED WITH TARGETED TEMPERATURE MANAGEMENT. RESUSCITATION. 2015 JUL;92:154-9). IN THIS PATIENT, THROMBUS WAS DIAGNOSED IN THE SAME VEIN AS ZOLL CATHETER WAS INSERTED ONE DAY AFTER CATHETER REMOVAL BY DOPPLER TEST. EVENT REPORTED AS NOT SERIOUS. THE SITE REPORTED THAT THE EVENT WAS NOT SERIOUS, RELATED TO THE PATIENT'S CLINICAL CONDITION, POSSIBLY RELATED TO THE STUDY DEVICE (CATHETER) AND NOT RELATED TO THE STUDY PROCEDURE. SEVEN DAYS AFTER CATHETER REMOVAL, THE PATIENT EXPERIENCED SYMPTOMS OF HYPOXIC MYOCLONUS. DUE TO A SEVERE HYPOXIC BRAIN DAMAGE, HE SHOWED REPETITIVE MYOCLONUS. THE SITE REPORTED THAT THE AE WAS SERIOUS (REQUIRED PROLONGED HOSPITALIZATION AND INTERVENTION TO PREVENT PERMANENT IMPAIRMENT), RELATED TO PATIENT'S CLINICAL CONDITION OF SEVERE HYPOXIC BRAIN DAMAGE, AND NOT RELATED TO THE STUDY DEVICE OR STUDY PROCEDURE. ONE MONTH POST CATHETER REMOVAL, THE PATIENT WAS DISCHARGED TO ACUTE REHABILITATION FACILITY IN A COMA AND VEGETATIVE STATE AND 4 MONTHS POST CATHETER REMOVAL, THE PATIENT EXPIRED DUE TO UNKNOWN CAUSE. THE SITE REPORTED THAT THE PATIENT'S DEATH WAS NOT RELATED TO STUDY DEVICE OR STUDY PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE ZOLL IVTM QUATTRO CATHETER USED DURING THE REPORTED EVENT WILL NOT BE RETURNED FOR INVESTIGATION. THEREFORE, A PHYSICAL INVESTIGATION WILL NOT BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE FILED IF THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED. THERE WERE NO REPORTS OF A DEVICE MALFUNCTION. IN ADDITION, THERE WERE NO VESSEL INJURIES CAUSED BY THE ZOLL CATHETER. PER ZOLL LABELING, POSSIBLE COMPLICATIONS WITH CENTRAL VENOUS CATHETERS INCLUDE THROMBOSIS. ADDITIONALLY, CATHETER RELATED THROMBOSIS ARE KNOWN COMPLICATIONS WITH INTRAVASCULAR CATHETER USE OF ANY KIND.

    Description of Event or Problem · 1

    A (B)(6) WHITE MALE WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2015 AT 23:00 WITH A PAST MEDICAL HISTORY OF HYPERTENSION. THE PATIENT WAS A CURRENT USER OF TOBACCO AND ALCOHOL. ON (B)(6) 2015, AT 20:53, THE PATIENT HAD A WITNESSED OUT OF OFFICE CARDIAC ARREST AT HOME. THE PATIENT DID NOT RECEIVE ANY BYSTANDER TREATMENT. EMS ARRIVED AT 21:00 AND PATIENT RECEIVED CPR AND DEFIBRILLATION. ROSC WAS ACHIEVED AT 21:21 WITH INITIAL RHYTHM OF VENTRICULAR FIBRILLATION. THE PATIENT WAS INTUBATED ON SCENE. AT ADMISSION, A PULSE RATE OF 80 BEATS PER MINUTE, BP VALUE OF 130/80 MM HG, AND RESPIRATORY RATE OF 14 BREATHS PER MIN WERE RECORDED. X-RAY HAD REVEALED A POSSIBLE PNEUMONIA DUE TO ASPIRATION. ON THE SAME DAY, IVTM QUATTRO CATHETER WAS SUCCESSFULLY INSERTED INTO THE LEFT FEMORAL VEIN AT 23:00 AND COOLING WAS INITIATED AT 23:20. REWARMING PROCEDURE BEGAN ON (B)(6) 2015 AT 01:00. CATHETER WAS REMOVED ON (B)(6) 2015 AT 16:30. ON (B)(6) 2015, AT 00:00, 2 DAYS AFTER INITIATION OF COOLING PROCEDURE, THE DAY AFTER REWARMING PROCEDURE WAS INITIATED, DURING NORMOTHERMIA, THE PATIENT EXPERIENCED SYMPTOMS OF URINARY TRACT INFECTION. THE PATIENT RECEIVED TREATMENT WITH MEDICATIONS. ADDITIONALLY, THE PATIENT SHOWED SYMPTOMS OF PNEUMONIA. THE PATIENT WAS INTUBATED FOR 2 DAYS AT THE TIME OF THE EVENT, AND RECEIVED VENTILATION WITH EVITA VENTILATOR. ANTIBIOTIC TREATMENT WAS STARTED WITHIN THE FIRST 24H AFTER ADMISSION WITH CEFTRIAXONE. ON (B)(6) 2015 AT 08:00, 6 DAYS POST INITIATION OF COOLING PROCEDURE, 16 HOURS AFTER CATHETER WAS REMOVED FROM LEFT FEMORAL VEIN, THE PATIENT EXPERIENCED SYMPTOMS OF SWOLLEN LEFT LEG AND LOCAL LIVID DISCOLORATION OF THE LEFT LEG. DEEP VEIN THROMBOSIS WAS DIAGNOSED WITH DOPPLER. THE PATIENT WAS ON HEPARIN ANTICOAGULATION SINCE (B)(6) 2015 AND THE TREATMENT CONTINUED WITH AN INCREASE IN THE DOSE OF HEPARIN FROM 200 IE/H TO 1000IE/H ON (B)(6) 2015. THE EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2015. ON (B)(6) 2015, AT 09:30, 12 DAYS POST INITIATION OF COOLING PROCEDURE, AND 7 DAYS AFTER CATHETER REMOVAL, THE PATIENT EXPERIENCED SYMPTOMS OF HYPOXIC MYOCLONUS. AFTER SEDATION REGIME THE PATIENT REMAINED COMATOSE DURING TIME AT ICU. THE PATIENT SHOWED A COMPLEX NEUROLOGICAL DYSFUNCTION IN ACCORDANCE WITH AN INTENSE MOVING DISORDER. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER ASSESSMENT. DUE TO A SEVERE HYPOXIC BRAIN DAMAGE, HE SHOWED REPETITIVE MYOCLONUS. TREATMENT WITH MEDICATIONS WAS INITIATED. NEUROLOGICAL ASSESSMENT REVEALED THE DIAGNOSIS OF HYPOXIC MYOCLONUS. ELECTROENCEPHALOGRAM (EEG) SHOWED NO STATUS EPILEPTICUS AT ANY TIME. PER THE SITE REPORTED THAT THE EVENT WAS SERIOUS AND ONGOING AT THE TIME OF THE REPORT, RELATED TO PATIENT'S CLINICAL CONDITION OF SEVERE HYPOXIC BRAIN DAMAGE, AND NOT RELATED TO THE STUDY DEVICE OR STUDY PROCEDURE (THERE WERE NO RELATION OR CONNECTION TO COOLING PROCEDURE). ON (B)(6) 2015, 1 MONTH POST CATHETER REMOVAL, THE PATIENT WAS DISCHARGED TO ACUTE REHABILITATION FACILITY IN A COMA AND VEGETATIVE STATE. ON (B)(6) 2015, AT 00:00, 4 MONTHS POST CATHETER REMOVAL, THE PATIENT EXPIRED DUE TO UNKNOWN CAUSE.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT WEIGHING (B)(6), ON (B)(6) 2015 EXPERIENCED A CARDIAC ARREST AT 20:53 AT HIS PLACE OF RESIDENCE. THE PATIENT DID NOT RECEIVE ANY TREATMENT PRIOR TO ARRIVAL OF EMS. EMS ARRIVED ON SCENE AT 21:00. BLS (BASIC LIFE SUPPORT) TECHNIQUES WERE ADMINISTERED TO THE PATIENT DURING TRANSPORT TO THE HOSPITAL. THE PATIENT WAS ALSO DEFIBRILLATED AND AT THE TIME OF THE FIRST RHYTHM ANALYSIS, THE PATIENT WAS FOUND TO BE A VENTRICULAR FIBRILLATION (VF) STATE. THE PATIENT RECEIVED COLD SALINE INFUSION PRIOR TO ARRIVAL AT THE HOSPITAL. HIS GLASGOW COMA SCORE WAS 3 WHICH INDICATED NO EYE OPENING AND NO VERBAL OR MOTOR RESPONSES. PATIENT WAS TRANSFERRED TO THE CATH LAB AT 21:40. THE PATIENT DID NOT RECEIVE COLD SALINE INFUSION OR ANY OTHER FORMS OF COOLING SUCH AS ICE PACKS OR SURFACE COOLING AFTER ARRIVAL AT THE HOSPITAL. A ZOLL IVTM QUATTRO CATHETER WAS SUCCESSFULLY INSERTED INTO THE LEFT FEMORAL VEIN AT 23:00H. COOLING WAS INITIATED ON (B)(6) 2015 AT 23:20H. THE PATIENT WAS REWARMED AT A RATE OF 0.25 DEGREES C/HOUR ON (B)(6) 2015 AT 1:00H. NORMOTHERMIA TARGET TEMPERATURE WAS SET TO 36 DEGREES C AND WAS ACHIEVED ON (B)(6) 2015 AT 9:00H. ON (B)(6) 2015, THE PATIENT EXPERIENCED PNEUMONIA AND A URETHRAL INFECTION DURING NORMOTHERMIA. THE PATIENT WAS INTUBATED AND VENTILATED WITH AN EVITA VENTILATOR AND ADMINISTERED MEDICATIONS. THE EVENTS WERE NOT RELATED TO THE DEVICE OR PROCEDURE. THE CATHETER WAS REMOVED ON (B)(6) 2015 AT 16:30H. ON (B)(6) 2015 AT 08:00, A DEEP VEIN THROMBOSIS OCCURRED IN THE SAME VEIN THAT THE CATHETER WAS INSERTED, ONE DAY AFTER THE CATHETER WAS REMOVED; EVEN THOUGH THE PATIENT HAD CONTINUOUSLY RECEIVED A LOW DOSE OF HEPARIN. FURTHER ANTICOAGULATION THERAPY WAS INITIATED. ON (B)(6) 2015 AT 09:30, THE PATIENT EXPERIENCED A BRAIN DISORDER (HYPOXIC MYOCLONUS), 7 DAYS AFTER THE CATHETER WAS REMOVED. THE EVENT WAS CONSIDERED SERIOUS BY THE SITE INVESTIGATOR, HOWEVER IT WAS NOT RELATED TO THE DEVICE OR PROCEDURE. AFTER SEDATION REGIME, THE PATIENT REMAINED COMATOSE DURING THE TIME SPENT AT THE ICU. THE PATIENT SHOWED A COMPLEX NEUROLOGICAL DYSFUNCTION IN ACCORDANCE WITH AN INTENSIVE MOVING DISORDER. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER ASSESSMENT AND RESIDES AT A LONG TERM SKILLED NURSING FACILITY. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705236 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION 8700-0697-40 UNKNOWN 00849111075114

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death| O