BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 14431481 · Received May 18, 2022

    Report

    Report Number
    3010617000-2022-00461
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 15, 2022
    Report Date
    July 12, 2022
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    NCX
    UDI-DI
    00849111075084
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS RECEIVED THE ICY CATHETER FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT THAT THE ICY CATHETER (LOT #170887) COULD NOT BE FULLY INSERTED WAS NOT CONFIRMED DURING FUNCTIONAL TESTING. NO ISSUES OR DISCREPANCIES WERE FOUND ON THE RETURNED CATHETER. NO DEVICE MALFUNCTION WAS OBSERVED DURING THE TESTING, AND THE CATHETER FUNCTIONED AS INTENDED. IT COULD BE LIKELY THAT A WRONG CATHETER WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. THE CATHETER MEMBRANE COVER WAS OBSERVED TO HAVE BEEN REMOVED. HOWEVER, THE CATHETER WAS RETURNED IN A NEW, UNUSED CONDITION. THERE WAS NO PHYSICAL DAMAGE ON THE CATHETER. NO BLOOD WAS OBSERVED ON THE CATHETER SHAFT, BALLOONS, OR LUERED TUBINGS. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI, NO ISSUES WERE OBSERVED. THE BALLOONS DID NOT LEAK DURING INFLATION AND DEFLATION. NO LEAKS WERE FOUND IN THE LUERS AND THE CATHETER 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 THROUGH THE DISTAL INFUSION LUERED PORT WITHOUT RESISTANCE. THE GUIDEWIRE COULD BE PASSED THROUGH THE ENTIRE LENGTH OF THE LUMEN WITH NO RESISTANCE.

    Additional Manufacturer Narrative · 0

    H10 (ADDITIONAL NARRATIVE/DATA) WAS CORRECTED. THE REPORTED COMPLAINT THAT THE ICY CATHETER (LOT #170887) COULD NOT BE FULLY INSERTED WAS NOT CONFIRMED DURING FUNCTIONAL TESTING. 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 CUSTOMER CONFIRMED THE CATHETER WAS CLEANED BEFORE BEING RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. THE CATHETER MEMBRANE COVER WAS OBSERVED TO HAVE BEEN REMOVED. THERE WAS NO PHYSICAL DAMAGE ON THE CATHETER. NO BLOOD WAS OBSERVED ON THE CATHETER SHAFT, BALLOONS, OR LUERED TUBINGS. FUNCTIONAL TESTING OF THE RETURNED CATHETER WAS PERFORMED. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE. DURING THE FUNCTIONAL PRESSURE LEAK TEST, THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, AND THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI, NO ISSUES WERE OBSERVED. THE BALLOONS DID NOT LEAK DURING INFLATION AND DEFLATION. NO LEAKS WERE FOUND IN THE LUERS AND THE CATHETER 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 THROUGH 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

    ON (B)(6) AT AROUND 2PM, THE PHYSICIAN TRIED TO PLACE THE ICY CATHETER (LOT #170887) ON RIGHT FEMORAL SITE BUT OBVIOUS RESISTANCE WAS OBSERVED AND THE CATHETER COULD NOT BE ADVANCED. THE PHYSICIAN CHANGED TO PLACE THE CATHETER ON LEFT FEMORAL SITE INSTEAD. THE GUIDEWIRE WAS SMOOTHLY INSERTED, BUT THE CATHETER COULD NOT BE FULLY PLACED (PICTURE ATTACHED). THE PHYSICIAN REMOVED THE DEVICES AND FOUND BOTH THE GUIDEWIRE AND THE CATHETER WERE KINKED AT THE DISTAL SECTIONS. THE GUIDEWIRE WAS INSPECTED BEFORE USE. A NEW CATHETER KIT WAS USED TO CONTINUE THE PROCEDURE. THE CATHETER PLACEMENT WAS SMOOTH (ON LEFT FEMORAL) USING THE NEW CATHETER AND GUIDEWIRE. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2762982 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION INC IC-3893AE 170887 00849111075084

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown