BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 7 CATHETER

    MDR report key: 16122588 · Received January 9, 2023

    Report

    Report Number
    3010617000-2023-00009
    Event Type
    Malfunction
    Date Received
    January 9, 2023
    Date of Event
    December 13, 2022
    Report Date
    January 9, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075305
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT THAT THE SOLEX 7 CATHETER (LOT# 171782) COULD NOT BE FULLY INSERTED WAS NOT CONFIRMED DURING FUNCTIONAL TESTING OF THE RETURNED CATHETER, HOWEVER, WAS CONFIRMED DURING THE INSPECTION OF THE RETURNED GUIDEWIRE. NO ISSUES OR DISCREPANCIES WERE FOUND ON THE RETURNED CATHETER. NO DEVICE MALFUNCTION WAS OBSERVED DURING THE TESTING, AND THE CATHETER FUNCTIONED AS INTENDED. THE GUIDEWIRE USED DURING THE REPORTED EVENT WAS RETURNED TO ZOLL FOR INVESTIGATION. THE GUIDEWIRE WAS COMPLETELY DAMAGED AS RECEIVED. THE GUIDEWIRE WAS KINKED, BENT, AND STRETCHED WIRE ALONG THE LENGTH OF THE GUIDEWIRE. THEREFORE, THE ROOT CAUSE OF THE REPORTED COMPLAINT OF "CATHETER COULD NOT BE INSERTED" WAS DUE TO A DAMAGED GUIDEWIRE, LIKELY ATTRIBUTED TO A HANDLING ISSUE AND/OR INSERTION OF THE GUIDEWIRE. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE CATHETERS. NO KINK WAS OBSERVED ON THE CATHETER. NOTICED DRIED BLOOD RESIDUES ON THE SERPENTINE BALLOONS AND IN DISTAL LUERED TUBINGS. A FUNCTIONAL PRESSURE LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI, NO LEAK WAS OBSERVED ON THE BALLOONS. NO LEAK OR DAMAGE WAS FOUND DURING TESTING, AND THE CATHETER WAS PERFORMED AS INTENDED. ADDITIONALLY, A GUIDEWIRE TEST WAS PERFORMED. A KNOWN-GOOD ZOLL GUIDEWIRE WAS SLOWLY INSERTED INTO THE TIP OF THE CATHETER AND EXITED TO THE DISTAL INFUSION LUERED PORT WITHOUT RESISTANCE. THE GUIDEWIRE COULD BE PASSED THROUGH THE ENTIRE LENGTH OF THE LUMEN WITH NO RESISTANCE.

    Description of Event or Problem · 0

    AS REPORTED, DURING THE SOLEX 7 CATHETER (LOT# 171782) PLACEMENT TO PERFORM THE IVTM THERAPY, THE CATHETER COULD NOT BE INSERTED BECAUSE IT COULD NOT BE ADVANCED OVER THE GUIDEWIRE TO THE NECESSARY DEPTH. THE PLACEMENT OF THE CATHETER WAS NOT ASSISTED BY IMAGING. THERE WERE NO OTHER LINES PLACED IN THE SAME VEIN. PER THE REPORTER, THE PHYSICIAN EXPERIENCED DIFFICULTY WITH THE CATHETER PLACEMENT. UPON GUIDEWIRE REMOVAL, THE CONDITION OF THE GUIDEWIRE WAS NOTED WITH FRAYED SECTIONS. THE PHYSICIAN DETERMINED THAT THE UNSUCCESSFUL INSERTION WAS NOT DUE TO TORTUOUS ANATOMY, BUT RATHER THE POOR INTEGRITY AND BREAKDOWN OF THE GUIDEWIRE. THE IVTM THERAPY WAS CONTINUED USING SURFACE TEMPERATURE MANAGEMENT. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2294718 ZOLL IVTM SOLEX 7 CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593 171782 00849111075305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown