BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 10389240 · Received August 11, 2020

    Report

    Report Number
    3010617000-2020-00841
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    July 16, 2020
    Report Date
    August 10, 2020
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075275
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF THE DIFFICULTY IN INSERTION OF THE QUATTRO CATHETER (LOT # 140874) OVER THE GUIDEWIRE WAS CONFIRMED DURING VISUAL INSPECTION AND FUNCTIONAL TESTING. ROOT CAUSE WAS DUE TO THE KINK ON THE SHAFT OF THE CATHETER LIKELY DUE TO USER ERROR. PER REPORTER, THE PHYSICIAN HAD NO EXPERIENCE WITH THE INSERTION OF A ZOLL CATHETER. THE IFU CONTAINS ADEQUATE INSTRUCTIONS, WARNING AND CAUTIONS (LISTED BELOW) FOR PREVENTING ADVANCEMENT/REMOVAL IF THERE IS A RESISTANCE OR EXERTING EXCESSIVE FORCE. WARNING: NEVER USE EXCESSIVE FORCE IN MOVING THE CATHETER OR GUIDEWIRE. IF RESISTANCE IS ENCOUNTERED, AN X-RAY SHOULD BE PERFORMED TO IDENTIFY THE REASON FOR THE RESISTANCE. CAUTION: AVOID ROUGH OR OVERLY VIGOROUS MANIPULATION OF THE GUIDEWIRE TO PREVENT DAMAGE TO THE GUIDEWIRE OR THE VESSEL. INSTRUCTION STEP 9: HOLD THE CATHETER AT THE DESIRED DEPTH AND REMOVE THE GUIDEWIRE. IF RESISTANCE IS ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE GUIDEWIRE AFTER CATHETER PLACEMENT, THE GUIDEWIRE MAY BE KINKED AT THE TIP OF THE CATHETER. IF RESISTANCE IS ENCOUNTERED, WITHDRAW THE CATHETER RELATIVE TO THE GUIDEWIRE ABOUT 2-3CM AND ATTEMPT TO REMOVE THE GUIDEWIRE. IF RESISTANCE IS ENCOUNTERED AGAIN, REMOVE THE GUIDEWIRE AND CATHETER SIMULTANEOUSLY. CAUTION: DO NOT APPLY UNDUE FORCE TO THE GUIDEWIRE. UPON VISUAL INSPECTION, A KINK WAS OBSERVED ON SHAFT OF THE QUATTRO CATHETER 10 CM AWAY FROM THE TIP OF THE CATHETER. THE BALLOONS WERE EXAMINED AND THERE WERE NO TEARS, BALLOON BOND DETACHMENT OR RUPTURE NOTED. OBSERVED BLOOD RESIDUE ON THE BALLOONS, ON DISTAL LUERED TUBING AND ALONG THE CATHETER SHAFT. DURING FUNCTIONAL PRESSURE LEAK TEST, ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE, EXCEPT THE DISTAL LUER PORT DUE TO CLOGGED BLOOD THUS CONFIRMING THE CUSTOMER REPORTED COMPLAINT OF THE LUMENS OF THE CATHETER WAS NOT EASILY FLUSHABLE. ADDITIONAL GUIDEWIRE TEST WAS PERFORMED USING A KNOWN GOOD GUIDEWIRE, UPON ADVANCING THE GUIDEWIRE FOR THE TIP OF THE CATHETER; RESISTANCE WAS OBSERVED AT 1 INCH FROM THE TIP. POSSIBLE ROOT CAUSE WAS DUE TO THE CATHETER WAS KINKED AT THE SHAFT. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, THE BALLOONS WERE FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI WITHOUT ANY ISSUES. THE BALLOONS DID NOT LEAK DURING INFLATION AND DEFLATION. NO LEAK WAS OBSERVED. ALL LUMENS FLUSHED AS INTENDED. DURING MANUFACTURING, ALL CATHETERS ARE 100% INSPECTED FOR LEAKS, DAMAGES OR KINKS 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 COMPLAINT REPORTED FOR A CATHETER WITH A LOT NUMBER 140874.

    Description of Event or Problem · 1

    DURING CATHETERIZATION, THE USER HAD DIFFICULTY IN INSERTION OF THE QUATTRO CATHETER (LOT # 140874) OVER THE GUIDEWIRE. FOLLOWING THIS, IT WAS OBSERVED THAT THE LUMENS OF THE CATHETER WAS NOT EASILY FLUSHABLE. THE CATHETER WAS THEN REPLACED WITH ANOTHER QUATTRO CATHETER AND WAS USED AS A CENTRAL LINE. NO CONSEQUENCES OR IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854463 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593AE 140874 00849111075275

    Patients

    Seq Age Sex Outcome Treatment
    1