BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 17196185 · Received June 25, 2023

    Report

    Report Number
    3010617000-2023-00543
    Event Type
    Malfunction
    Date Received
    June 25, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 25, 2023
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF "BALLOON DAMAGE ON THE COOL LINE CATHETER (LOT #182117) CAUSED THE SALINE BAG DECREASED" WAS CONFIRMED DURING FUNCTIONAL TESTING OF THE RETURNED CATHETER. A LEAK WAS OBSERVED FROM THE PROXIMAL END OF THE DISTAL BALLOON DUE TO A BALLOON TEAR. THE PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT WAS A LATENT MATERIAL DEFECT. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED, AND NO PHYSICAL DAMAGE WAS FOUND ON THE CATHETER. OBSERVED BLOOD RESIDUES IN THE DISTAL AND PROXIMAL LUERED TUBINGS. DURING FUNCTIONAL TESTING, ALL INFUSION PORTS AND LUMEN WERE FLUSHED WITHOUT RESISTANCE. UPON FLUSHING THE IN/OUT LUMENS, THE LEAK WAS OBSERVED FROM THE PROXIMAL END OF THE DISTAL BALLOON, CONFIRMING THE REPORTED COMPLAINT. DURING FURTHER INSPECTION OF THE CATHETER UNDER A MICROSCOPE, A SMALL BALLOON TEAR WAS OBSERVED (MEASURED 1MM), LOCATED 1.5 CM AWAY FROM THE PROXIMAL END OF THE DISTAL BALLOON. PRESSURIZED FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE LEAK DISCOVERED DURING THE IN/OUT LUMEN TEST. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. DURING MANUFACTURING, ALL CATHETERS ARE 100% INSPECTED FOR LEAKS BY SUBJECTING THEM TO PRESSURE TESTING. ONLY UNITS THAT PASSED ARE MOVED TO THE NEXT PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO SIMILAR COMPLAINT REPORTED FOR THE COOL LINE CATHETER WITH LOT NUMBER 182117.

    Description of Event or Problem · 0

    DURING IVTM THERAPY, THE COOL LINE CATHETER (LOT #182117) WAS INSERTED INTO THE PATIENT'S INTERNAL JUGULAR VEIN. THE CUSTOMER NOTICED THE SALINE IN THE SALINE BAG DECREASED TO A FEW MILLILITER. THE SALINE LEAK FROM SUK WAS NOT FOUND, SO THE CUSTOMER CONCLUDED BALLOON DAMAGE CAUSED THE SALINE BAG DECREASED AND ENDED IVTM THERAPY. THE COOL LINE CATHETER WAS CONTINUED TO BE USED AS A CV CATHETER, AND LATER THE PHYSICIAN REMOVED THE CATHETER. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930973 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION CL-2295 182117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown