BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM COOL LINE CATHETER

    MDR report key: 11427191 · Received March 7, 2021

    Report

    Report Number
    3010617000-2021-00206
    Event Type
    Malfunction
    Date Received
    March 7, 2021
    Date of Event
    February 7, 2021
    Report Date
    March 5, 2021
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF THE BALLOON ON THE COOL LINE CATHETER (LOT #150061) WAS DAMAGED WAS CONFIRMED. OBSERVED DISTAL BALLOON BURSTS IMMEDIATELY UPON PRESSURIZING AND A LEAK WAS OBSERVED AT MIDDLE OF DISTAL BALLOON. PROBABLE CAUSE FOR THE REPORTED COMPLAINT CAN BE A LATENT MATERIAL DEFECT. VISUAL EXAMINATION OF THE RETURNED CATHETER WAS PERFORMED. OBSERVED BLOOD RESIDUES IN THE BALLOONS AND LUERED TUBING. ALL LUMENS WERE FLUSHED WITHOUT RESISTANCE, EXCEPT IN/OUT LUERS DUE TO BLOOD CLOGGED. FUNCTIONAL LEAK TEST OF THE RETURNED CATHETER WAS PERFORMED. THE RETURNED CATHETER WAS CONNECTED TO THE PRESSURIZED INFLATION DEVICE AND UPON PRESSURIZING THE CATHETER, THE DISTAL BALLOON BURSTS IMMEDIATELY AND A LEAK WAS OBSERVED AT MIDDLE OF DISTAL BALLOON, THUS CONFIRMING CUSTOMER COMPLAINT. 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. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR A CATHETER WITH A LOT NUMBER 150061.

    Description of Event or Problem · 1

    DURING IVTM THERAPY FOR A PATIENT WITH SUBARACHNOID HEMORRHAGE, CUSTOMER NOTICED THE THERMOGARD SYSTEM DISPLAYED AN "CIRCULATION ERROR" AND OBSERVED BLOOD IN THE START-UP KIT (LOT #145889). PER REPORTER, THE BALLOON ON THE COOL LINE CATHETER (LOT #150061) WAS DAMAGED. IVTM THERAPY WAS DISCONTINUED. NO CONSEQUENCES OR IMPACT TO PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2021-00256 FOR THE THERMOGARD IVTM SYSTEM (SN UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324895 ZOLL IVTM COOL LINE CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION CL-2295 150061

    Patients

    Seq Age Sex Outcome Treatment
    1