BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLEX® INTRAVASCULAR HEAT EXCHANGE

    MDR report key: 24537647 · Received March 6, 2026

    Report

    Report Number
    3010617000-2026-00128
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    February 8, 2026
    Report Date
    March 6, 2026
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    PMA / PMN Number
    K081936
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED CATHETER LEAK COMPLAINT WAS CONFIRMED DURING FUNCTIONAL TESTING OF THE RETURNED SOLEX 7 CATHETER (LOT#: 200929). A WATER EMISSION OR LEAK WAS OBSERVED FROM THE DISTAL END OF THE MANIFOLD DURING THE LUMEN CROSSTALK TEST. THE PROBABLE ROOT CAUSE IS A WEAKENED WALL BETWEEN THE LUMENS, WHICH WITHSTOOD PRESSURE TESTING DURING MANUFACTURING BUT RESULTED IN A LEAK DURING CLINICAL USE. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL THE INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. THE DISTAL INFUSION PORT WAS TESTED AND FUNCTIONED AS INTENDED. NO LEAKS WERE OBSERVED IN THE DISTAL LUERED TUBING OR THE CATHETER SHAFT DURING FLUSHING. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE RETURNED CATHETER WAS CONNECTED TO THE PRESSURIZED INFLATION; THE BALLOON WAS FULLY INFLATED TO 100 PSI, AND NO LEAK WAS OBSERVED FROM THE BALLOON. HOWEVER, A WATER EMISSION OR LEAK WAS OBSERVED FROM THE DISTAL END OF THE MANIFOLD DURING THE LUMEN CROSSTALK TEST, CONFIRMING THE REPORTED COMPLAINT. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. ALL CATHETERS ARE 100% INSPECTED FOR LEAKS DURING MANUFACTURING 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 PREVIOUS HISTORY OF COMPLAINTS FOR THE SOLEX 7 CATHETER LOT#: 200929. THE EVENT WAS ASSESSED AS NOT SERIOUS BECAUSE IT DOES NOT MEET THE CRITERIA FOR SERIOUSNESS. A BANDAGE WAS APPLIED TO REDUCE SWELLING. BASED ON AVAILABLE INFORMATION, THE EVENT WAS PROBABLY RELATED TO THE ZOLL CATHETER DUE TO RELEVANT TIMING AND LOCATION. THE REPORTED EVENT IS PROBABLY RELATED TO THE DEVICE AND TO THE PROCEDURE.

    Description of Event or Problem · 0

    A 67-YEAR-OLD MALE POST-CARDIAC ARREST PATIENT (BODY WEIGHT: 85 KG) UNDERWENT INTRAVASCULAR TEMPERATURE MANAGEMENT (IVTM) THERAPY USING A SOLEX 7 CATHETER (LOT#: 200929). THE CATHETER WAS SUCCESSFULLY INSERTED INTO THE LEFT INTERNAL JUGULAR VEIN ON THE FIRST ATTEMPT BY AN EXPERIENCED CLINICIAN. CORRECT CATHETER PLACEMENT WAS CONFIRMED BY BOTH X-RAY AND ULTRASOUND IMAGING. NO ADDITIONAL VASCULAR LINES WERE PLACED IN THE SAME VEIN. AT THE INITIATION OF IVTM THERAPY, THE PATIENT'S TEMPERATURE WAS 35.7 °C. THE TARGET TEMPERATURE WAS SET TO 34.0 °C WITH THE MAXIMUM COOLING RATE SELECTED. AT THE TIME THE ISSUE WAS IDENTIFIED, THE PATIENT'S TEMPERATURE WAS 34.2 °C. APPROXIMATELY 24 HOURS AFTER CATHETER PLACEMENT, SWELLING AT THE INSERTION SITE WAS OBSERVED, CONSISTENT WITH PARAVASAL INFUSION AND LOCALIZED SUBCUTANEOUS FLUID ACCUMULATION. THE TREATING PHYSICIAN ESTIMATED THAT APPROXIMATELY 10 ML OF STEROFUNDIN AND SEDATION MEDICATION MAY HAVE BEEN INFUSED SUBCUTANEOUSLY. THE THERMOGARD CONSOLE GENERATED NO ALARMS DURING THERAPY. BEFORE THE ISSUE WAS DETECTED, THE PATIENT HAD BEEN TRANSPORTED TO THE CT SCANNER. IT IS SUSPECTED, THOUGH NOT YET CONFIRMED BY WEEKEND STAFF, THAT A HIGH-PRESSURE INJECTOR PUMP MAY HAVE BEEN CONNECTED TO THE CATHETER DURING THIS PERIOD. UPON RECOGNITION OF THE SWELLING, THE SOLEX 7 CATHETER WAS IMMEDIATELY REMOVED AND REPLACED WITH A NEW CATHETER INSERTED ON THE CONTRALATERAL SIDE. A BANDAGE WAS APPLIED TO REDUCE SWELLING. NO SKIN DAMAGE WAS OBSERVED, AND THE PATIENT REMAINED STABLE THROUGHOUT. IVTM THERAPY WAS RESUMED AND CONTINUED WITHOUT FURTHER COMPLICATIONS. A LEAK TEST OF THE REMOVED SOLEX 7 CATHETER WAS PERFORMED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). TESTING OF THE DISTAL INFUSION PORT IDENTIFIED A LEAK APPROXIMATELY 1 CM ALONG THE CATHETER SHAFT, NOT INVOLVING THE BALLOONS. EXTERNAL LEAKAGE WAS OBSERVED ONLY AFTER CATHETER REMOVAL AND DURING THE LEAK TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600590 SOLEX® INTRAVASCULAR HEAT EXCHANGE INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. SL-2593AE 200929

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other