BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20102717 · Received August 29, 2024

    Report

    Report Number
    3010617000-2024-00677
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    July 26, 2024
    Report Date
    October 2, 2024
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    PMA / PMN Number
    K081936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF DIFFICULTY IN INSERTING A CATHETER WAS CONFIRMED DURING THE VISUAL AND FUNCTIONAL TESTING OF THE RETURNED SOLEX 7 CATHETER (LOT #201227). A KINK ON THE SHAFT WAS OBSERVED AT THE PROXIMAL END OF THE SERPENTINE BALLOON (8 CM AWAY FROM THE CATHETER TIP), RESULTING IN DIFFICULTY INSERTING THE CATHETER OVER THE GUIDEWIRE. THE EXACT TIMING AND CAUSE OF THE KINK ON THE CATHETER CANNOT BE DETERMINED, BUT USER HANDLING OR INSERTION OF THE CATHETER CANNOT BE RULED OUT. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED, AND IT WAS FOUND THAT THE CATHETER SHAFT WAS KINKED AT THE PROXIMAL END OF THE SERPENTINE BALLOON (8 CM AWAY FROM THE CATHETER TIP). FUNCTIONAL FLUSHING OF THE CATHETER WAS PERFORMED. ONLY THE DISTAL LUMEN WAS FLUSHED WITHOUT RESISTANCE. THE PROXIMAL AND MEDIAL LUMENS CANNOT FLUSH DUE TO BLOOD CLOGGING IN THE TUBINGS, AND THE IN/OUT LUMEN CANNOT FLUSH DUE TO THE KINKED SERPENTINE BALLOON SHAFT. DUE TO THE CONDITION IN WHICH THE CATHETER WAS RECEIVED, THE FUNCTIONAL PRESSURE LEAK TEST COULD NOT BE PERFORMED. AN ADDITIONAL GUIDEWIRE TEST WAS PERFORMED: A KNOWN-GOOD ZOLL GUIDEWIRE WAS SLOWLY INSERTED THROUGH THE CENTRAL LUMEN OF THE CATHETER; STARING AT THE TIP OF THE CATHETER, THE GUIDEWIRE GOT STUCK AT 8 CM AWAY FROM THE CATHETER TIP DUE TO THE KINKED ON THE SERPENTINE BALLOON SHAFT. HISTORICAL COMPLAINTS WERE REVIEWED FOR INVESTIGATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE SOLEX 7 CATHETER WITH LOT #201227.

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT RECEIVED THE SOLEX 7 CATHETER FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF AND WHEN THE PRODUCT IS RETURNED, AND THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    WHILE PREPARING TO PLACE THE SOLEX 7 CATHETER (LOT #201227) TO INITIATE AN IVTM THERAPY FOR A FEMALE PATIENT (WEIGHT - 75 KG), THE CUSTOMER COULD NOT LOCATE THE SPECIFIC GUIDEWIRE IN THE CABINET AND SUBSEQUENTLY SELECTED AN ALTERNATIVE ONE. THE CUSTOMER INSERTED A SOLEX CATHETER INTO THE RIGHT INTERNAL JUGULAR VEIN. THE INSERTION WAS DIFFICULT, AND IT TOOK TWO ATTEMPTS TO PLACE THE CATHETER. AFTER PLACING THE CATHETER, THE CUSTOMER ENCOUNTERED DIFFICULTY ASPIRATING FROM THE DISTAL LUER. THE CUSTOMER TRIED TO REPOSITION THE CATHETER WITH A DIFFERENT GUIDEWIRE (NON-ZOLL GUIDEWIRE) BECAUSE THE ZOLL GUIDEWIRE COULD NOT BE ADVANCED, AS IT GOT STUCK 15CM FROM THE MANIFOLD. THE CATHETER WAS SUBSEQUENTLY REMOVED, AND A NEW SOLEX CATHETER WAS SUCCESSFULLY INSERTED WITHOUT ANY ISSUES. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096361 SOLEX® INTRAVASCULAR HEAT EXCHANGE CATHETER KIT CUSTOM LUER APPLAUSE HEPARIN EU INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM CATHETER NCX ZOLL CIRCULATION, INC. SL-2593AE 201227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown