BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 15252522 · Received August 18, 2022

    Report

    Report Number
    3010617000-2022-01527
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    June 13, 2022
    Report Date
    August 18, 2022
    Manufacturer
    ZOLL CIRCULATION INC
    Product Code
    NCX
    UDI-DI
    00849111075084
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INVESTIGATION ON (B)(6) 2022, A BONDING LEAK WAS OBSERVED AT DISTAL END OF PROXIMAL BALLOON ICY CATHETER (LOT #170780) DURING FUNCTIONAL TESTING. THE PROBABLE ROOT CAUSE COULD BE A LATENT DEFECT AT THE BOND. VISUAL INSPECTION OF THE RETURNED CATHETER WAS PERFORMED. THE CATHETER SHAFT WAS OBSERVED TO BE KINKED AT 10 CM AWAY FROM THE CATHETER TIP. BLOOD RESIDUE WAS NOTICED IN THE BALLOONS AND LUERED TUBINGS. NO OTHER PHYSICAL DAMAGE WAS OBSERVED. THE EXACT TIMING AND CAUSE OF THE KINK ON THE CATHETER CANNOT BE DETERMINED; HOWEVER, IMPROPER HANDLING OF THE CATHETER CANNOT BE RULED OUT. FUNCTIONAL LEAK TEST 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. UPON PRESSURIZING THE CATHETER UP TO 100 PSI, A BONDING LEAK WAS OBSERVED AT DISTAL END OF PROXIMAL BALLOON. 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 ONE SIMILAR COMPLAINT REPORTED FOR THE ICY CATHETER WITH LOT NUMBER 170780. CCR (B)(4), REPORTED ON (B)(6) 2022. THERE WAS A BALLOON BOND LEAK.

    Description of Event or Problem · 0

    DURING THE INVESTIGATION ON (B)(6) 2022, A BONDING LEAK WAS OBSERVED AT DISTAL END OF PROXIMAL BALLOON ICY CATHETER (LOT #170780). NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278491 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION INC IC-3893 170780 00849111075084

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown