BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 10269118 · Received July 14, 2020

    Report

    Report Number
    3010617000-2020-00710
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 18, 2020
    Report Date
    July 13, 2020
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075282
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF THE GUIDEWIRE (LOT # 140684) WOULD NOT RETRACT FROM THE QUATTRO CATHETER (LOT # 140684) WAS CONFIRMED DURING FUNCTIONAL TESTING. KINK ON THE CATHETER'S PROBABLE ROOT CAUSE WAS LIKELY DUE TO MISHANDLING. 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 GUIDE 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. DURING VISUAL INSPECTION, THE GUIDEWIRE WAS STUCK INSIDE THE QUATTRO CATHETER AND NOTICED A KINK ON THE CATHETER SHAFT AT THE PROXIMAL END OF THE DISTAL BALLOON. NO OTHER PHYSICAL DAMAGES OBSERVED ON THE CATHETER. BLOOD RESIDUE WAS OBSERVED ON THE CATHETER'S BALLOONS AND ALONG THE CATHETER. INITIALLY, THE GUIDEWIRE WAS UNABLE TO BE REMOVED FROM THE CATHETER DUE TO CLOGGED BLOOD. THE GUIDEWIRE WAS REMOVED FROM THE CATHETER BY FLUSHING DISTAL LUMEN. UPON REMOVING THE GUIDEWIRE FROM THE CATHETER, FUNCTIONAL TESTING WAS PERFORMED. USING A KNOWN GOOD GUIDEWIRE, WHEN ADVANCING THE GUIDEWIRE FROM THE TIP OF THE CATHETER, RESISTANCE WAS OBSERVED AT THE PROXIMAL END OF THE DISTAL BALLOON, POSSIBLE DUE TO THE CATHETER WAS SLIGHTLY KINKED AT THE SITE. THE CAUSE OF THE KINKED INSIDE THE CATHETER WAS UNKNOWN. ALL INFUSION PORTS AND EXTENSION TUBES WERE FLUSHED WITHOUT RESISTANCE. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE, THE BALLOONS FULLY INFLATED WHEN PRESSURIZED UP TO 100 PSI WITHOUT ANY ISSUES. NO DAMAGES OR LEAKS WERE OBSERVED. THE CATHETER PERFORMED AS INTENDED. THE GUIDEWIRE WAS STUCK INSIDE THE CATHETER, THE GUIDEWIRE COULD BE REMOVED FROM THE CATHETER BY FLUSHING DISTAL LUMEN. THE CATHETER WAS ALSO KINKED, SO IT IS NOT POSSIBLE TO DETERMINE IF THE KINKED GUIDEWIRE CAUSED THE REPORTED ISSUE OR THE KINKED CATHETER. REGARDLESS OF WHICH WAS KINKED FIRST, THE MOST LIKELY CAUSE IS MISHANDLING. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO COMPLAINT REPORTED FOR A CATHETER WITH A LOT NUMBER 140684. PER ZOLL MEDICAL SAFETY ASSESSMENT, DURING CATHETERIZATION OF A 50 YEARS OLD FEMALE PATIENT USING ULTRASOUND GUIDE, THE USER HAD DIFFICULTY IN ADVANCING THE GUIDEWIRE. AFTER THE GUIDEWIRE ADVANCED, THE USER HAD DIFFICULTY IN ADVANCING THE QUATTRO CATHETER. ONCE THE CATHETER WAS IN PLACE, THE GUIDEWIRE WOULD NOT RETRACT AND THE USER REMOVED THE CATHETER AND GUIDEWIRE. FOLLOWING THIS, THE PATIENT HAD SIGNIFICANT BLEEDING THE REQUIRED PRESSURE AND FEM STOP. THIS WAS AN EXPERIENCED PROVIDER. CUSTOMER STATED THERE WERE NO ANATOMICAL ISSUES IN THIS PATIENT. THE PATIENT WAS CRITICALLY ILL BUT STABLE AND IVTM THERAPY DISCONTINUED, NO NEED FOR HYPOTHERMIA ANYMORE (STABLE ICP, END OF VASOSPASM PERIOD). NO PATIENT INJURY OR DEATH REPORTED. EVENT OF BLEEDING WAS NOT SERIOUS BECAUSE REQUIRED NO INTERVENTION BUT ONLY APPLICATION OF PRESSURE. EVENT OF BLEEDING AT THE INSERTION SITE WAS PROBABLY RELATED TO ZOLL CATHETER DUE TO THE RELEVANT LOCATION AND TIMING.

    Description of Event or Problem · 1

    DURING CATHETERIZATION OF A (B)(6) YEARS OLD FEMALE PATIENT ON THE RIGHT FEMORAL USING ULTRASOUND GUIDE, THE USER HAD DIFFICULTY IN ADVANCING THE GUIDEWIRE. AFTER THE GUIDEWIRE ADVANCED, THE USER HAD DIFFICULTY IN ADVANCING THE QUATTRO CATHETER. ONCE THE CATHETER WAS IN PLACE, THE GUIDEWIRE WOULD NOT RETRACT AND THE USER REMOVED THE CATHETER AND GUIDEWIRE. FOLLOWING THIS, THE PATIENT HAD SIGNIFICANT BLEEDING THAT REQUIRED PRESSURE AND FEM STOP. PATIENT HAD NO ISSUE ONCE BLEEDING WAS CONTROLLED. ADJUNCT THERAPY WAS PERFORMED. MFR 3010617000-2020-00709 REFERENCES THE GUIDEWIRE USED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736106 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 140684 00849111075282

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR