BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DQY CATHETER, PERCUTANEOUS

    MDR report key: 6714879 · Received July 14, 2017

    Report

    Report Number
    1820334-2017-01658
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Report Date
    December 15, 2017
    Manufacturer
    COOK INC
    Product Code
    DQY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PROCODE. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND TRENDS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE LOT NUMBER FOR THIS COMPLAINT DEVICE IS UNKNOWN. CONSEQUENTLY, THE WORK ORDER RECORD OR ITS RELATED NON-CONFORMANCES COULD NOT BE EVALUATED. ADDITIONALLY, IT COULD NOT BE DETERMINED IF ADDITIONAL COMPLAINTS FROM THE SAME LOT HAVE BEEN REPORTED. COMPLAINT SAMPLE EVALUATION WAS NOT PERFORMED SINCE NO PRODUCT OR IMAGING WAS RETURNED TO ASSIST WITH THIS INVESTIGATION. THE EXACT RPN'S AND LOT NUMBERS USED IN THIS STUDY ARE UNKNOWN. HOWEVER, IT IS ASSUMED THAT THE RPN'S ASSOCIATED WITH THIS COMPLAINT INCLUDE C-UD[T][Q]LM DEVICES WITH BH, BASED ON THE TEXT WITHIN THE PAPER. SINCE THE DATES OF MANUFACTURE OF THESE DEVICES ARE ALSO UNKNOWN, DOCUMENT REVIEW WAS DONE ON CURRENT DOCUMENT VERSIONS. BIOCOMPATIBILITY TESTING FOR PROLONGED DURATION WAS PERFORMED ON HEPARIN COATED CENTRAL VENOUS CATHETER SETS ACCORDING TO EN ISO 10993-1 AND INCLUDED HEMOLYSIS TESTING, WHICH PASSED. ADDITIONALLY, THE TERM THROMBOSIS WAS DEFINED IN THE CATCH TRIAL AS ¿TWO EPISODES WITHIN 5 DAYS OF EACH OTHER OF DIFFICULTY FLUSHING THE CENTRAL VENOUS CATHETER OR DRAWING BACK BLOOD FROM THE CENTRAL VENOUS CATHETER, ONE EPISODE OF SWOLLEN LIMB, CENTRAL VENOUS CATHETER REMOVAL BECAUSE OF THROMBOSIS, OR A POSITIVE ULTRASOUND INDICATING THROMBOSIS¿. THERE ARE SEVERAL FAILURE MODES INCLUDED IN THAT DEFINITION AND THE BREAKDOWN OF OCCURRENCES OF EACH IS UNKNOWN. THE IFU FOR THIS DEVICE RECOMMENDS, ¿PRELIMINARY REPORTS INDICATE THAT CATHETER SIZE CAN INFLUENCE CLOTTING; LARGER DIAMETER CATHETERS TEND TO PROMOTE CLOTS¿THE CATHETER SIZE SHOULD BE AS SMALL AS THE USE WILL ALLOW.¿ THE IFU ALSO STATES, ¿FOR HEPARIN COATED DEVICES, STANDARD FLUSHING PROCEDURES ARE RECOMMENDED.¿ IT ALSO GOES OVER THE FLUSHING AND FILLING OF LUMENS WITH HEPARINIZED SALINE SOLUTION TO PREVENT CLOTTING OR EMBOLUS PRIOR TO CATHETER INSERTION. IF A CATHETER IS IN A SMALL VEIN AND THE SIDE HOLE IS AGAINST THE VESSEL WALL YOU MAY NOT BE ABLE TO FLUSH- THIS DOESN¿T MEAN THERE IS A THROMBOSIS, BUT BASED ON THE CATCH DEFINITION IF THIS OCCURRED TWICE IT WOULD HAVE BEEN REGISTERED AS A THROMBOSIS. BASED ON THE AVAILABLE INFORMATION IT IS NOT CLEAR IF THE LEADING CAUSE TO THIS EVENT MIGHT BE ASSOCIATED WITH THE PATIENT CONDITION, THE MEDICAL PROCEDURE, OR AN EVENTUAL MALFUNCTION OF THE DEVICE. WITHOUT VISUAL, DIMENSIONAL, OR FUNCTIONAL TESTING OF THE INVOLVED COMPONENTS OR ADDITIONAL INFORMATION, WE ARE UNABLE TO DETERMINE WITH CERTAINTY WHAT LED TO THIS FAILURE MODE. THIS FAILURE MODE IS BEING ESCALATED PER INTERNAL PROCESSES. WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    GILBERT, RUTH E, ET AL,. IMPREGNATED CENTRAL VENOUS CATHETERS FOR PREVENTION OF BLOODSTREAM INFECTION IN CHILDREN (THE CATCH TRIAL): A RANDOMIZED CONTROLLED TRIAL. LANCET 2016; 387:1732-42. THE ABOVE REFERENCED JOURNAL ARTICLE REPORTS THE RESULTS OF A RANDOMIZED TRIAL COMPARING THREE TYPES OF CENTRAL VENOUS CATHETERS FOR THE PREVENTION OF BLOODSTREAM INFECTION. PATIENTS WERE RANDOMIZED TO THREE CATHETER STUDY GROUPS: A) STANDARD CENTRAL VENOUS CATHETERS (N= 502), B) ANTIBIOTIC- IMPREGNATED CENTRAL VENOUS CATHETERS (N= 486) OR C) HEPARIN-IMPREGNATED CENTRAL VENOUS CATHETERS (N=497.) CATHETER THROMBOSIS OCCURRED IN 125 PATIENTS (25%) OF THOSE IN THE STANDARD CATHETER GROUP, 126 PATIENTS (26%) IN THE ANTIBIOTIC-IMPREGNATED CATHETER GROUP AND 105 PATIENTS (21%) IN THE HEPARIN-IMPREGNATED GROUP. THIS REPORT ADDRESSES THE PATIENTS ENTERED INTO THE HEPARIN-IMPREGNATED CENTRAL VENOUS CATHETER GROUP. THE INITIAL REPORTER STATES THAT THE CATCH TRIAL RESULTS SHOWED A TREND TOWARDS INCREASED THROMBOSIS BUT IT DID NOT REACH SIGNIFICANCE. THIS IS ONE OF SIX MEDWATCH REPORTS BEING SUBMITTED TO ADDRESS THE EVENTS IDENTIFIED IN THE JOURNAL ARTICLE REFERENCED ABOVE. REFERENCE MDR NUMBERS 1820334-2017-00827, 1820334-2017-01654, 1820334-2017-01655, 1820334-2017-01656 AND 1820334-2017-01657.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495568 DQY CATHETER, PERCUTANEOUS DQY COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1