BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 20243031 · Received September 17, 2024

    Report

    Report Number
    3010617000-2024-00754
    Event Type
    Injury
    Date Received
    September 17, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 17, 2024
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    UDI-DI
    00849111075312
    PMA / PMN Number
    K101987
    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 A KINKED CATHETER WAS CONFIRMED DURING THE VISUAL INSPECTION OF THE RETURNED SOLEX 7 CATHETER. THE CATHETER WAS RETURNED TO ZOLL WITH ITS SHAFT COMPLETELY DAMAGED. THE SHAFT WAS OBSERVED TO BE KINKED AT TWO LOCATIONS ON THE SERPENTINE BALLOON. 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 TWO LOCATIONS ON THE SERPENTINE BALLOON, LOCATED 2.5 CM AND 7.5 CM AWAY FROM THE CATHETER TIP. FUNCTIONAL FLUSHING OF THE CATHETER WAS PERFORMED. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE, EXCEPT FOR THE IN/OUT LUMEN DUE TO THE SEVERE KINK ON 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 RESULTS RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE SOLEX 7 CATHETER WITH LOT NUMBER 186920.

    Description of Event or Problem · 0

    WHILE ATTEMPTING TO INSERT THE SOLEX 7 CATHETER (LOT #186920) INTO THE PATIENT'S RIGHT FEMORAL VEIN, THE INSERTION SITE WAS WELL DILATED, AND THE GUIDEWIRE ADVANCED SMOOTHLY. HOWEVER, THE CATHETER WAS FOUND TO BE KINKED. CONSEQUENTLY, THE CATHETER WAS NEITHER INSERTED NOR REPLACED. NO INTERVENTION WAS NECESSARY OR PLANNED. THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION. THE PATIENT IS ALIVE WITHOUT ANY REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319458 SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. SL-2593AE 186920 00849111075312

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown