BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM

    MDR report key: 16626755 · Received March 28, 2023

    Report

    Report Number
    3006425876-2023-00344
    Event Type
    Death
    Date Received
    March 28, 2023
    Date of Event
    January 12, 2023
    Report Date
    March 1, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K962577
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), THE CUSTOMER RETURNED ONE 4-L CVC CATHETER FOR ANALYSIS. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED ON THE CATHETER BODY. IT WAS NOTED THAT THE BOX CLAMP ASSEMBLY WAS ON THE CATHETER BODY. VISUAL ANALYSIS OF THE CATHETER, CLAMP FASTENER, AND CLAMP CATHETER DID NOT REVEAL ANY DEFECTS OR ANOMALIES. ADHESIVE TAPE WAS OBSERVED OVER THE JUNCTURE HUB. PER CONFIRMATION FROM THE CUSTOMER, "BOTH WINGS WERE SECURED PROPERLY"; HOWEVER, IT IS UNKNOWN IF THIS WAS DONE VIA SUTURES OR VIA THE OBSERVED TAPE. LIKEWISE, NO SUTURES WERE OBSERVED ON THE BOX CLAMP ASSEMBLY NOR THE JUNCTURE HUB. THE OUTER DIAMETER OF THE RETURNED CATHETER BODY MEASURED TO BE 2.904MM, WHICH IS WITHIN SPECIFICATIONS OF 2.87MM-2.97MM PER PRODUCT DRAWING. THE INNER DIAMETER OF THE CLAMP FASTENER MEASURED 4.4704MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 4.32MM - 4.57MM PER THE CLAMP FASTENER PRODUCT DRAWING. FUNCTIONAL INSPECTION WAS PERFORMED PER THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THE KIT WHICH STATES, "USE A CATHETER STABILIZATION DEVICE , CATHETER CLAMP AND FASTENER, STAPLES OR SUTURES (WHERE PROVIDED). USE CATHETER HUB AS PRIMARY SECUREMENT SITE. USE CATHETER CLAMP AND FASTENER AS A SECONDARY SECUREMENT SITE AS NECESSARY". THE CATHETER JUNCTURE HUB WAS SECURED WITHIN A VICE AND THE BOX CLAMP WAS ATTACHED TO THE CATHETER BODY. TO TEST THE AXIAL CLAMP HOLDING FORCE, THE BOX CLAMP ASSEMBLY WAS THEN ATTACHED TO A FORCE GAUGE. PER AMRQ-000145 REV04, GENERATION 1 COMBINATIONS OF THE CLAMP/FASTENER FOR CATHETERS LARGER THAN 7FR SHOULD SUSTAIN A WITHDRAWAL FORCE OF = 6N (1.35LBS). THE BOX CLAMP ASSEMBLY WAS PULLED IN THE DIRECTION OF THE CATHETER BODY TO 1.35LBS. NO MOVEMENT WAS OBSERVED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "USE A CATHETER STABILIZATION DEVICE, CATHETER CLAMP AND FASTENER, STAPLES OR SUTURES (WHERE PROVIDED). USE CATHETER HUB AS PRIMARY SECUREMENT SITE. USE CATHETER CLAMP AND FASTENER AS A SECONDARY SECUREMENT SITE AS NECESSARY". THE CUSTOMER REPORT OF A CATHETER MIGRATION COULD NOT BE CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS DID NOT REVEAL ANY DEFECTS OR ANOMALIES. FUNCTIONAL TESTING CONFIRMED NO MOVEMENT OF THE BOX CLAMP ASSEMBLY WHEN ATTACHED TO THE CATHETER. THE PRIMARY SUTURE LOCATION FOR THIS CATHETER IS THE JUNCTURE HUB USING THE SUTURE WINGS. IT COULD NOT BE DETERMINED IF THE BOX CLAMP OR THE JUNCTURE HUB SUTURE WINGS WERE SECURED; THEREFORE, THE PROBABLE CAUSE COULD NOT BE DETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT "THE CENTRAL VEIN CATHETER HAS SLIPPED OUT OF THE FIXATION." A USER REPORT WAS RECEIVED REPORTING THAT "DISPLACEMENT OF THE CENTRAL VENOUS CATHETER WITHOUT THE BLUE CLIP BEING SNAPPED OFF OR LOOSELY ATTACHED. THE WINGS ARE ATTACHED TO THE SKIN. THE PATIENT DOES NOT MOVE, HE IS ANESTHETIZED. WHEN I TAKE THE ACCESS OF THE CENTRAL CATHETER WHICH IS IN THE PATIENT'S BED, IT SLIDES EASILY INTO THE WING. (PATIENT'S BODY TEMPERATURE). THE SYSTEM IS NOT BLOCKED. WHEN THE CATHETER IS NO LONGER IN CONTACT WITH THE PATIENT BUT HAS BEEN AT ROOM TEMPERATURE FOR SEVERAL HOURS, IT NO LONGER MOVES IN THE WINGS." IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT CONSEQUENCE WAS EMERGENCY REPOSITIONING OF TWO PERIPHERAL LINES, PRESSURE DRESSING AND PLACEMENT IN THE TRENDELENBURG POSITION. THE PATIENT WAS REPORTED TO BE DECEASED (B)(6) 2023 UNRELATED TO THE DEVICE. THE CAUSE OF DEATH WAS REPORTED BY THE CUSTOMER AS "PROGRESSION OF HEART AND RESPIRATORY FAILURE".

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT "THE CENTRAL VEIN CATHETER HAS SLIPPED OUT OF THE FIXATION." A USER REPORT WAS RECEIVED REPORTING THAT "DISPLACEMENT OF THE CENTRAL VENOUS CATHETER WITHOUT THE BLUE CLIP BEING SNAPPED OFF OR LOOSELY ATTACHED. THE WINGS ARE ATTACHED TO THE SKIN. THE PATIENT DOES NOT MOVE, HE IS ANESTHETIZED. WHEN I TAKE THE ACCESS OF THE CENTRAL CATHETER WHICH IS IN THE PATIENT'S BED, IT SLIDES EASILY INTO THE WING. (PATIENT'S BODY TEMPERATURE). THE SYSTEM IS NOT BLOCKED. WHEN THE CATHETER IS NO LONGER IN CONTACT WITH THE PATIENT BUT HAS BEEN AT ROOM TEMPERATURE FOR SEVERAL HOURS, IT NO LONGER MOVES IN THE WINGS." IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT CONSEQUENCE WAS EMERGENCY REPOSITIONING OF TWO PERIPHERAL LINES, PRESSURE DRESSING AND PLACEMENT IN THE TRENDELENBURG POSITION. THE PATIENT WAS REPORTED TO BE DECEASED (B)(6) 2023 UNRELATED TO THE DEVICE. THE CAUSE OF DEATH WAS REPORTED BY THE CUSTOMER AS "PROGRESSION OF HEART AND RESPIRATORY FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480389 ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC IPN029771

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Death CONTINUOUS NOREPINEPHRINE| CONTINUOUS NOREPINEPHRINE