BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRE, GUIDE, CATHETER

    MDR report key: 10269117 · Received July 14, 2020

    Report

    Report Number
    3010617000-2020-00709
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 18, 2020
    Report Date
    July 13, 2020
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DQX
    PMA / PMN Number
    K770977
    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. 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. 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. THE GUIDEWIRE WAS STUCK INSIDE THE QUATTRO CATHETER. NOTICE KINKED GUIDEWIRE AT 1.5 INCHES AWAY FROM DISTAL END OF THE CATHETER. INITIALLY, THE GUIDEWIRE WAS UNABLE TO BE REMOVED FROM THE CATHETER DUE TO BLOOD CLOGGED. THE GUIDEWIRE WAS ABLE TO BE REMOVED FROM THE CATHETER BY FLUSHING DISTAL LUMEN WITH EFFORT IN ORDER TO DISSOLVE THE CLOGGED BLOOD INSIDE THE LUMEN AND PULLING BACK THE GUIDEWIRE FROM THE TIP OF THE CATHETER. UPON REMOVAL, THE GUIDEWIRE WAS OBSERVED TO HAVE TWO KINKS ALONG THE GUIDEWIRE MEASURED AT 11 AND 16 INCHES FROM THE J HOOK. UNABLE TO PERFORM FURTHER TESTING DUE TO THE CONDITION IN WHICH THE GUIDEWIRE WAS RECEIVED. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO COMPLAINT REPORTED FOR A GUIDEWIRE WITH A LOT NUMBER 140684. PER ZOLL MEDICAL SAFETY ASSESSMENT, DURING CATHETERIZATION OF A (B)(6) 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) 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 3010617000-2020-00710 REFERENCES THE QUATTRO CATHETER USED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736105 WIRE, GUIDE, CATHETER CENTRAL VENOUS CATHETER DQX ZOLL CIRCULATION, INC 8700-0664-01 140684

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR