BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU

    MDR report key: 20026172 · Received August 22, 2024

    Report

    Report Number
    3010617000-2024-00623
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 16, 2024
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075312
    PMA / PMN Number
    K101987
    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 COMPLAINT OF DIFFICULTY IN REMOVING THE CATHETER WAS CONFIRMED DURING THE VISUAL INSPECTION OF THE RETURNED SOLEX 7 CATHETER. THE CATHETER WAS RETURNED TO ZOLL WITH ITS SHAFT AND SERPENTINE BALLOON COMPLETELY DAMAGED. THE SHAFT WAS OBSERVED TO BE KINKED AT THE PROXIMAL END OF THE SERPENTINE BALLOON. IN ADDITION, THE SERPENTINE BALLOON WAS ALSO OBSERVED TO BE DAMAGED BECAUSE IT WAS CUT BY THE CUSTOMER AS DESCRIBED IN THE EVENT DESCRIPTION FOR MEDICAL INTERVENTION TO REMOVE THE CATHETER. THE EXACT TIMING AND CAUSE OF THE KINK ON THE CATHETER CANNOT BE DETERMINED; HOWEVER, USER HANDLING OF THE CATHETER CANNOT BE RULED OUT. DURING VISUAL INSPECTION, THE CATHETER SHAFT WAS OBSERVED TO BE KINKED AT THE PROXIMAL END OF THE SERPENTINE BALLOON, LOCATED 8 CM AWAY FROM THE CATHETER TIP. ALSO, THE CUSTOMER HAD CUT OFF THE SERPENTINE BALLOON (LOOP 7TH). DURING FUNCTIONAL FLUSHING OF THE CATHETER, THE DISTAL AND THE IN/OUT LUMEN COULD NOT BE FLUSHED DUE TO THE SEVERE KINK ON THE SHAFT AND THE DAMAGE TO THE SERPENTINE BALLOON. DUE TO THE CONDITION IN WHICH THE CATHETER WAS RECEIVED, THE FUNCTIONAL PRESSURE LEAK TEST COULD NOT BE PERFORMED. HISTORICAL COMPLAINTS WERE REVIEWED FOR INVESTIGATION RESULT RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE SOLEX 7 CATHETER WITH LOT NUMBER 192581. THE EVENT WAS SERIOUS BECAUSE REQUIRED SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING INJURY. BASED ON AVAILABLE INFORMATION, THE EVENT'S RELATIONSHIP TO THE ZOLL CATHETER IS CASUAL. CATHETER REMOVAL DIFFICULTY IS AN ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR WITH THE USAGE OF ANY CATHETER. THE REPORTED EVENT IS CASUALLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE.

    Description of Event or Problem · 0

    A PATIENT WITH SEPSIS RECEIVED INTRAVASCULAR TEMPERATURE MANAGEMENT (IVTM) THERAPY TO TREAT FEVER. THE SOLEX 7 CATHETER (LOT #192581) WAS SMOOTHLY INSERTED INTO THE PATIENT'S RIGHT INTERNAL JUGULAR VEIN. THE PATIENT'S TEMPERATURE AT THE START OF IVTM THERAPY WAS 40.9 °C, AND ICE PACKS WERE USED ON THE PATIENT PRIOR TO COOLING VIA IVTM THERAPY. THE TARGET TEMPERATURE WAS SET TO 37.4 °C AT THE MAX RATE TO COOL THE PATIENT. AT THE END OF THE TREATMENT, THE SOLEX 7 CATHETER WAS ASPIRATED TO BE REMOVED TO TERMINATE THE TREATMENT. HOWEVER, THE CATHETER COULD NOT BE REMOVED EVEN WITH ROTATING MOVEMENTS. THE CATHETER CAME OUT OF THE VEIN PARTIALLY, BUT IT GOT STUCK. IT APPEARED THAT THE CATHETER BALLOON HAD BECOME WEDGED TOGETHER. THE CATHETER WAS ASPIRATED AND ROTATED AGAIN. THE INSERTION SITE WAS DILATED TO CUT THROUGH THE PART OF THE CATHETER BALLOON THAT WAS STILL INSIDE THE VEIN, AND THE CATHETER WAS REMOVED. THE DWELL TIME OF THE CATHETER WAS 55 HOURS. THE ENTIRE CATHETER BALLOON WAS REMOVED, AND NOTHING REMAINED IN THE VESSEL. THERE WAS NO MAJOR AFTER-BLEEDING, AND THE WOUND WAS TREATED WITH A PRESSURE BANDAGE. NO PATIENT INJURY WAS REPORTED, AND THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014966 SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. SL-2593AE 192581 00849111075312

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other