BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 10273952 · Received July 14, 2020

    Report

    Report Number
    3010617000-2020-00662
    Event Type
    Death
    Date Received
    July 14, 2020
    Date of Event
    June 13, 2020
    Report Date
    April 15, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075282
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    STERILE SALINE ON BED OR FLOOR NOT REPORTED. THE PATIENT'S CONDITION DID NOT IMPROVE. THE PATIENT WAS MADE DNR AND EXTUBATED WITH THE INTENTION OF KEEPING HER COMFORTABLE UNTIL SHE EXPIRED ON (B)(6) 2020. ACCORDING TO DEATH CERTIFICATE, CAUSE OF DEATH WAS MYOCARDIAL INFARCTION. NO INJURY OR DEATH REPORTED AS ATTRIBUTABLE TO ZOLL PRODUCT. IN THE OPINION OF THE CUSTOMER, THE PATIENT'S DEATH WAS NOT RELATED TO THE SALINE INFUSION RESULTING FROM THE LEAK IN THE ZOLL CATHETER. EVENT OF DEATH IS SERIOUS AS MEETS CRITERION OF SERIOUSNESS (DEATH). INVESTIGATION AT ZOLL CONFIRMED QUATTRO CATHETER LEAK, WHICH CONFIRMED COLD STERILE SALINE INFUSION IN THE PATIENT'S VASCULATURE. THE SHAFT AT THE PROXIMAL BALLOON WAS OBSERVED KINKED, WHICH EXPLAINED RESISTANCE DURING CATHETER REMOVAL. BECAUSE THERE WERE NO SIGNS OF WET BED OR FLOOR, SEEMS THAT MAXIMUM AMOUNT OF STERILE SALINE ENTERED INTO THE PATIENT'S VASCULATURE WAS 200-300 ML FROM A CLOSE CIRCLE DUE TO A HOLE. INFUSION OF SUCH AMOUNT LIKELY DID NOT CONTRIBUTE TO PATIENT'S DEATH. IT IS KNOWN THAT ADMINISTRATION OF STERILE SALINE I.V. UP TO 1.5 L IS ONE OF THE COMMON METHODS OF TREATMENT AT THE HOSPITALS. CAUSE OF DEATH MYOCARDIAL INFARCTION WAS MORE LIKELY A PREEXISTING CONDITION THAT ORIGINALLY CAUSED CARDIAC ARREST. THE PATIENT WAS IN CRITICAL CONDITION POST RESUSCITATION AND PASSED AWAY NEXT DAY AFTER ADMISSION.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT ABOUT THE QUATTRO CATHETER (LOT # 141936) LEAK WAS CONFIRMED. DURING THE FUNCTIONAL LEAK TEST, A PINHOLE LEAK WAS OBSERVED IN THE MIDDLE OF THE MEDIAL 1 BALLOON. THE PROBABLE ROOT CAUSE OF THE PINHOLE LEAK WAS DUE TO A LATENT MATERIAL DEFECT. THE REPORTED COMPLAINT OF THE USER EXPERIENCED RESISTANCE DURING THE REMOVAL OF THE CATHETER WAS CONFIRMED THROUGH VISUAL INSPECTION. THE SHAFT AT THE PROXIMAL BALLOON (11 INCHES AWAY FROM THE CATHETER TIP) WAS OBSERVED KINKED. THE TIMING OF THE KINK CANNOT BE DETERMINED, THE SHAFT KINK COULD CAUSE RESISTANCE DURING THE CATHETER REMOVAL, HOWEVER, AN INCOMPLETE DEFLATION OF THE BALLOONS COULD NOT BE RULED OUT. VISUAL EXAMINATION OF THE RETURNED CATHETER WAS PERFORMED AND FOUND KINKED ON THE SHAFT AT THE PROXIMAL BALLOON (11 INCHES AWAY FROM THE CATHETER TIP). ALSO, OBSERVED BLOOD RESIDUE ON THE BALLOONS AND ON THE IN/OUT LUERS TUBINGS. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE FOR ONE MINUTE, THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI. IMMEDIATELY UPON PRESSURIZING THE CATHETER, A PINHOLE LEAK WAS OBSERVED IN THE MIDDLE OF THE MEDIAL 1 BALLOON. THEREFORE, THE REPORTED COMPLAINT WAS CONFIRMED. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. DURING MANUFACTURING, ALL CATHETERS ARE 100% INSPECTED FOR LEAKS BY SUBJECTING THEM TO PRESSURE TESTING. ONLY UNITS THAT PASSED ARE MOVED TO THE NEXT PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO SIMILAR COMPLAINT REPORTED FOR THE QUATTRO CATHETER WITH LOT NUMBER 141936 THE PATIENT WAS IN CRITICAL CONDITION POST RESUSCITATION AND PASSED AWAY NEXT DAY AFTER ADMISSION. EVENT OF DEATH IS SERIOUS AS MEETS CRITERION OF SERIOUSNESS (DEATH). INVESTIGATION AT ZOLL CONFIRMED QUATTRO CATHETER LEAK, WHICH CONFIRMED COLD STERILE SALINE INFUSION IN THE PATIENT'S VASCULATURE. THE SHAFT AT THE PROXIMAL BALLOON WAS OBSERVED KINKED, WHICH EXPLAINED RESISTANCE DURING CATHETER REMOVAL. RESISTANCE IN CATHETER POOLING PROBABLY DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. SEEMS THAT HOLE IN A BALLOON WAS A RESULT OF MECHANICAL PULLING EFFORT AND STERILE COLD SALINE DID NOT ENTER THE PATIENT'S VASCULATURE IN A SIGNIFICANT VOLUME OVER THE TIME. AT THE SAME TIME, ADMINISTRATION OF STERILE SALINE I.V. UP TO 1.5 L IS ONE OF THE COMMON METHODS OF TREATMENT AT THE HOSPITALS.

    Description of Event or Problem · 1

    THE (B)(6)-YEAR-OLD FEMALE PATIENT ((B)(6) KG) WAS HOSPITALIZED POST-CARDIAC ARREST AND UNDERWENT THERAPEUTIC HYPOTHERMIA. PER THE REPORTER, THE PATIENT'S FAMILY DECLINED A CARDIAC CATHETERIZATION PROCEDURE ON ADMISSION. THE PATIENT HAD A MEDICAL HISTORY OF HEART FAILURE, DIABETES MELLITUS (DM) TYPE 2, HYPERTENSION, OBSTRUCTIVE SLEEP APNEA (OSA) ON CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP). ALSO, THE PATIENT WAS DIAGNOSED WITH ACUTE KIDNEY INJURY POST-RESUSCITATION. ON (B)(6) 2020 AT 21:30, THE ZOLL QUATTRO CATHETER WAS INSERTED INTO THE PATIENT TO START THE IVTM THERAPY. FOLLOWING DAY, AT 06:45, THE CONSOLE GENERATED AN "AIR TRAP" ALARM AND THE BLOOD WAS NOTICED BACKING UP IN THE CATHETER TUBING. THERE WAS NO CONSOLE MALFUNCTION REPORTED. THE HOSPITAL NURSE ATTEMPTED TO REMOVE THE CATHETER, HOWEVER, MET A RESISTANCE. PER THE NURSE, THE BALLOONS WERE DEFLATED BEFORE THE WITHDRAWAL OF THE CATHETER. THE PHYSICIAN WAS ABLE TO REMOVE THE CATHETER. AFTER THE CATHETER REMOVAL, THE CATHETER WAS INSPECTED AND A HOLE WAS IDENTIFIED IN ONE OF THE MEDIAL BALLOONS OF THE QUATTRO CATHETER. THE COOLING THERAPY WAS DISCONTINUED AND THE MEDICATION INFUSION USED BY THE CATHETER WAS RELOCATED TO THE PERIPHERAL VEIN. THE CATHETER WAS NOT REPLACED, HOWEVER, SPECIFICS OF THE ALTERNATIVE THERAPY WERE NOT DISCLOSED. THE DO-NOT-RESUSCITATE (DNR) ORDER WAS PRODUCED AND THE PATIENT WAS EXTUBATED. PER THE REPORTER, THE PATIENT EXPIRED LATER IN THE DAY DUE TO THE MYOCARDIAL INFARCTION, DEATH WAS UNRELATED TO THE CATHETER LEAK EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735511 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 141936 00849111075282

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death