BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 7 CATHETER

    MDR report key: 6493773 · Received April 14, 2017

    Report

    Report Number
    3010617000-2017-00304
    Event Type
    Malfunction
    Date Received
    April 14, 2017
    Date of Event
    March 15, 2017
    Report Date
    July 14, 2017
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075305
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL SAFETY ASSESSMENT RESULT: EVENT WAS NOT SERIOUS BECAUSE DID NOT REQUIRE ANY ADDITIONAL TREATMENT AND THERE WERE NO ANY CLINICAL SYMPTOMS EXPERIENCED BY THE PATIENT, THROMBUS WAS AN OBSERVATION DURING CATHETER REMOVAL. VENOUS THROMBOEMBOLIC EVENTS (VTE) ARE COMMON AMONG PATIENTS WITH TRAUMATIC BRAIN INJURY (TBI). IF LEFT UNTREATED IT MAY RESULT IN LETHAL PULMONARY THROMBOEMBOLISM (PE). PREVIOUS STUDIES HAVE SUGGESTED THAT INTRACRANIAL HEMORRHAGE SERVES AS AN INDEPENDENT RISK FACTOR FOR THE DEVELOPMENT OF DVT. STUDIES WERE CONDUCTED TO DETERMINE THE ASSOCIATION OF TBI TO THE FORMATION OF DVT IRRESPECTIVE OF THE USE OF ANTICOAGULATION THERAPY. THE INCIDENCE OF DVT AMONG PATIENTS WITH TBI APPEARED TO BE HIGH. MULTIPLE STUDIES HAVE ADDRESSED DVT CHEMOPROPHYLAXIS TIMING IN TRAUMATIC BRAIN INJURIES. A COMPREHENSIVE LITERATURE REVIEW ON BRAIN INJURIES WAS PERFORMED AND TWENTY-THREE PUBLICATIONS INCLUDING MORE THAN 5,000 PATIENTS. IT WAS REPORTED THAT THE 54% HEAD INJURY PATIENTS HAD DEVELOPED DVT. [REIFF DA1, HARICHARAN RN, BULLINGTON NM, GRIFFIN RL, MCGWIN G JR, RUE LW 3RD. TRAUMATIC BRAIN INJURY IS ASSOCIATED WITH THE DEVELOPMENT OF DEEP VEIN THROMBOSIS INDEPENDENT OF PHARMACOLOGICAL PROPHYLAXIS. J TRAUMA. 2009 MAY; 66(5):1436-40]. IT WAS PUBLISHED THAT VTE AFTER TBI REPRESENTS A CLINICAL CHALLENGE. PHYSICIANS MUST BALANCE APPROPRIATE TIMING OF CHEMOPROPHYLAXIS WITH RISK OF INCREASED CEREBRAL HEMORRHAGE. ALTHOUGH TRAUMA IS A WELL-ESTABLISHED ETIOLOGY FOR THROMBOEMBOLIC EVENTS, ONLY IN THE PAST DECADE HAVE TBI PATIENTS BEEN RECOGNIZED WITH AN INCREASED RISK FOR VTE. THIS IS MOST LIKELY DUE TO LENGTHY HOSPITAL IMMOBILIZATION COMBINED WITH DELAYS IN VTE DRUG REGIMEN PROPHYLAXIS. ADDITIONALLY, THE NATIVE LEVELS OF CIRCULATING INFLAMMATORY CYTOKINES IN TBI PATIENTS FAVOR SYSTEMIC HYPERCOAGULATION. LITERATURE IMPLIES THAT IN PATIENTS WITH TBI, DVT CHEMOPROPHYLAXIS IS REASONABLE ON DAY 4. [HIBA ABDEL-AZIZ, C MICHAEL DUNHAM, REMA J MALIK, AND BARBARA M HILEMAN. TIMING FOR DEEP VEIN THROMBOSIS CHEMOPROPHYLAXIS IN TRAUMATIC BRAIN INJURY: AN EVIDENCE-BASED REVIEW. CRIT CARE. 2907015; 19(1): 96.]. THE EVIDENCE HAS DIRECTED THE AMERICAN COLLEGE OF CHEST PHYSICIANS TO RECOMMEND PROPHYLAXIS AND TREATMENT OF VTE IN TBI PATIENTS. [STUART GLASSNER, D.O., KARAN SRIVASTAVA, PAUL COFNAS, BRIAN DEEGAN, PETER DEMARIA, RIMSKY DENIS, AND ENRIQUE GINZBURG, M.D. PREVENTION OF VENOUS THROMBOTIC EVENTS IN BRAIN INJURY: REVIEW OF CURRENT PRACTICES. RAMBAM MAIMONIDES MED J. 2013 JAN; 4(1)]. ANOTHER STUDY SHOWED THAT THE INCIDENCE OF DVT IN THE GENERAL NEUROSURGICAL POPULATION RANGES BETWEEN 19 AND 50%. [PIERCE C: SURVEILLANCE BIAS AND DEEP VEIN THROMBOSIS IN THE NATIONAL TRAUMA DATA BANK: THE MORE WE LOOK, THE MORE WE FIND. THE JOURNAL OF TRAUMA_ INJURY, INFECTION, AND CRITICAL CARE, 2007; SWANN KW, BLACK P30M: DEEP VEIN THROMBOSIS AND PULMONARY EMBOLI IN NEUROSURGICAL PATIENTS: A REVIEW. J NEUROSURG 61:1055-1062, 1984]. DVT PROPHYLAXIS WAS PERFORMED IN THIS PATIENT. AS A CONCLUSION, EVENT IS PROBABLY RELATED TO THE COOL LINE CATHETER DUE TO RELEVANT TIMING AND LOCATION. AT THE SAME TIME, THE PATIENT'S CLINICAL CONDITION OF HEAD TRAUMA MADE THE PATIENT PREDISPOSED TO THROMBOGENICITY AND DEVELOPMENT OF THROMBUS, AS A COMMON COMPLICATION IS SUCH PATIENTS, AND THIS EVENT IS PROBABLY RELATED TO THE PATIENT'S CLINICAL CONDITION AS WELL. CORRECTION: EVENT DATE: WAS CHANGED FROM (B)(6) 2017 TO (B)(6) 2017.

    Additional Manufacturer Narrative · 1

    THE SOLEX CATHETER WAS RETURNED ON (B)(6) 2017 FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED CATHETER FOUND THAT THE 5-LUERED TUBINGS WERE CUT OFF. DRIED BLOOD CLOT WAS FOUND ON THE BALLOONS. BASED ON THE CONDITION OF THE RETURNED DEVICE, FURTHER TESTING INCLUDING BUT NOT LIMITED TO, LEAK, LUMEN AND CROSS TALK TESTING COULD NOT BE PERFORMED. THE LOT NUMBER OF THE SOLEX CATHETER WAS NOT PROVIDED; THUS, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. IN SUMMARY, THE REPORTED COMPLAINT OF BLOOD CLOT FOUND ON THE BALLOONS WAS CONFIRMED DURING THE VISUAL EXAMINATION OF THE CATHETER. THE EVALUATION OF THE CATHETER WAS LIMITED DUE TO THE CONDITION OF THE RETURNED DEVICE. IT IS UNKNOWN IF THE PATIENT WAS IN A HIGH RISK CATEGORY FOR DVT. DVT PROPHYLAXIS WAS GIVEN TO THE PATIENT. NO FURTHER TESTING WAS DONE TO DETERMINE IF THE PATIENT DEVELOPED THROMBUS.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT WEIGHING (B)(6) WAS HOSPITALIZED DUE TO HEAD TRAUMA ON (B)(4) 2017 AND UNDERWENT HYPOTHERMIA TREATMENT FOR FEVER MANAGEMENT. A ZOLL SOLEX CATHETER WAS INSERTED INTO THE RIGHT SUBCLAVIAN VEIN BY AN EXPERIENCED PHYSICIAN ON (B)(6) 2017 AT 1400 HOURS. THE IN DWELL TIME OF THE CATHETER WAS 6 DAYS. AT THE END OF THE TEMPERATURE MANAGEMENT THERAPY, A CLOT WAS FOUND ON THE CATHETER DURING CATHETER REMOVAL. IT IS UNKNOWN IF THE PATIENT WAS IN A HIGH RISK CATEGORY FOR DVT. DVT PROPHYLAXIS WAS GIVEN TO THE PATIENT. NO FURTHER TESTING WAS DONE TO DETERMINE IF THE PATIENT DEVELOPED THROMBUS.

    Description of Event or Problem · 1

    A (B)(6) PATIENT WEIGHING 86 KG WAS HOSPITALIZED DUE TO HEAD TRAUMA AND UNDERWENT HYPOTHERMIA TREATMENT FOR FEVER MANAGEMENT. A ZOLL SOLEX CATHETER WAS INSERTED INTO THE RIGHT SUBCLAVIAN VEIN BY AN EXPERIENCED PHYSICIAN. THE IN DWELL TIME OF THE CATHETER WAS 6 DAYS. AT THE END OF THE TEMPERATURE MANAGEMENT THERAPY, A CLOT WAS FOUND ON THE CATHETER DURING CATHETER REMOVAL. IT IS UNKNOWN IF THE PATIENT WAS IN A HIGH RISK CATEGORY FOR DVT. DVT PROPHYLAXIS WAS GIVEN TO THE PATIENT. NO FURTHER TESTING WAS DONE TO DETERMINE IF THE PATIENT DEVELOPED THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274635 ZOLL IVTM SOLEX 7 CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593 UNK 00849111075305

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR