BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB

    MDR report key: 17124641 · Received June 14, 2023

    Report

    Report Number
    9680794-2023-00430
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 17, 2023
    Report Date
    May 17, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). ASSOCIATED MDR#S: 9680794-2023-00431, 9680794-2023-00428, 9680794-2023-00429, 9680794-2023-00463, 9680794-2023-00430 THE CUSTOMER RETURNED ONE SHEATH FOR ANALYSIS. SIGNS OF USE WERE OBSERVED. VISUAL ANALYSIS OF THE SHEATH REVEALED NO OBVIOUS DEFECTS OR ANOMALIES. THE OVERALL LENGTH OF THE SHEATH MEASURED 100MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 98MM-102MM PER THE SHEATH PRODUCT DRAWING. THE OUTER DIAMETER OF THE SHEATH MEASURED 4.67MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 4.59MM - 4.71MM PER THE SHEATH EXTRUSION GRAPHIC. THE VALVE AND MAC DEVICE WERE LEAK TESTED ACCORDING TO THREE DIFFERENT PARAMETERS PER AMRQ-000038 REV12. 1) LOW PRESSURE LEAK RESISTANCE TEST (AMRQ-000038 SECTION 7.2.6): THIS STATES, "USING A TEST PRESSURE OF 38 - 42 KPA MAINTAINED FOR 30S, THERE SHALL BE NO LEAKAGE SUFFICIENT TO FORM ONE OR MORE FALLING DROPS OF WATER." THE MAC CATHETER WAS ATTACHED TO THE LAB LEAK TESTER. WITH THE DISTAL END OF THE SHEATH OCCLUDED, THE SHEATH WAS PRESSURIZED TO 42KPA FOR 30 SECONDS. NO LEAKING WAS OBSERVED. 2) LIQUID LEAKAGE - HEMOSTASIS VALVE WITH CATHETER INSERTED: THE PARAMETERS FROM THE LOW-PRESSURE LEAK RESISTANCE TEST WERE REPEATED WITH A LAB INVENTORY CATHETER INSERTED INTO THE SHEATH. THE SHEATH WAS PRESSURIZED WITH TO 42KPA FOR 30 SECONDS AND NO LEAKS WERE OBSERVED FROM THE HEMOSTASIS VALVE. 3) HIGH PRESSURE LEAK RESISTANCE TEST (AMRQ-000038 SECTION 7.2.5): THIS STATES, "WHEN TESTED AS DESCRIBED IN ANNEX D OF BS EN ISO 11070, USING A TEST PRESSURE OF 300 - 320 KPA MAINTAINED FOR 30S, THERE SHALL BE NO LEAKAGE SUFFICIENT TO FORM ONE OR MORE FALLING DROPS OF WATER." WITH BOTH THE DISTAL END OF THE SHEATH AND THE HEMOSTASIS VALVE OCCLUDED, THE DEVICE WAS PRESSURIZED TO 200KPA FOR 30SECONDS. NO LEAKS WERE DETECTED FROM ANY PORTION OF THE MAC, WHICH INDICATES THAT THE SHEATH ASSEMBLY IS INTACT. A MANUAL TUG TEST CONFIRMED THAT THE DISTAL AND PROXIMAL EXTENSION LINES ARE SECURE WITHIN THEIR RESPECTIVE LUER HUBS. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. THE CUSTOMER REPORT OF A CATHETER BODY LEAK COULD NOT BE CONFIRMED THROUGH INVESTIGATION OF THE RETURNED SAMPLE. THE SHEATH PASSED ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS (INCLUDING LEAK TESTING PERFORMED PER BS EN ISO 11070) AND A DEVICE HISTORY RECORD REVIEW PERFORMED BASED ON A POTENTIAL LOT FROM SALES HISTORY REVEALED NO RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, NO PROBLEM WAS FOUND. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON REPORTS OF THIS NATURE. CORRECTED DATA: SECTION D.1.-BRAND NAME CORRECTED TO ARROW MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB SECTION D.4.-CATALOG# CORRECTED TO CDC-21142-XCN1A

    Additional Manufacturer Narrative · 0

    (B)(4) ASSOCIATED MDR#S: 9680794-2023-00431, 9680794-2023-00428, 9680794-2023-00429, 9680794-2023-00463.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CATHETER "IS GETTING A TRICKLE OF CLEVIPREX BACKFLOWING INTO THE BROWN DISTAL LUMEN WHEN IT IS NOT IN USE OR CLA MPED". THE MEDICATION WAS ADMINISTERED THROUGH THE PROXIMAL PORT OF THE SWAN CATHETER AND WAS BACKFLOWING UP THROUGH THE BROWN DISTAL PORT OF THE MAC CATHETER. IT WAS REPORTED THE ISSUE HAS OCCURRED WITH 5 DEVICES IN DIFFERENT PATIENTS OVER THE LAST 5 WEEKS. THE USER DREW THE REFLUXED CLEVIPREX OUT OF THE LINE AND MOVED THE VASOPRESSOR TO A DIFFERENT PORT. A NEW LINE WAS NOT PLACED. IT WAS REPORTED "ALL PATIENT WERE CRITICAL STATUS AS THE INSTANCES OCCURRED SHORTLY AFTER ARRIVING TO THE ICU POST-OPEN HEART SURGERY. PATIENTS MAY OR MAY NOT HAVE REQUIRED ADDITIONAL MEDICATION TITRATION FOR MANAGEMENT OF HEMODYNAMIC STABILITY, BUT AGAIN, WE ARE UNABLE TO CONFIRM THIS RELATED TO THEIR RECENT SURGICAL PROCEDURE AND INHERENT BP CHANGES."

    Description of Event or Problem · 0

    IT WAS REPORTED THE CATHETER "IS GETTING A TRICKLE OF CLEVIPREX BACKFLOWING INTO THE BROWN DISTAL LUMEN WHEN IT IS NOT IN USE OR CLAMPED". THE MEDICATION WAS ADMINISTERED THROUGH THE PROXIMAL PORT OF THE SWAN CATHETER AND WAS BACKFLOWING UP THROUGH THE BROWN DISTAL PORT OF THE MAC CATHETER. IT WAS REPORTED THE ISSUE HAS OCCURRED WITH 5 DEVICES IN DIFFERENT PATIENTS OVER THE LAST 5 WEEKS. THE USER DREW THE REFLUXED CLEVIPREX OUT OF THE LINE AND MOVED THE VASOPRESSOR TO A DIFFERENT PORT. A NEW LINE WAS NOT PLACED. IT WAS REPORTED "ALL PATIENT WERE CRITICAL STATUS AS THE INSTANCES OCCURRED SHORTLY AFTER ARRIVING TO THE ICU POST-OPEN HEART SURGERY. PATIENTS MAY OR MAY NOT HAVE REQUIRED ADDITIONAL MEDICATION TITRATION FOR MANAGEMENT OF HEMODYNAMIC STABILITY, BUT AGAIN, WE ARE UNABLE TO CONFIRM THIS RELATED TO THEIR RECENT SURGICAL PROCEDURE AND INHERENT BP CHANGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409813 ARROW MAC KIT: 2-L 9 FR DISTAL X 10 CM AGB WIRE GUIDE CATHETER DQX ARROW INTERNATIONAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CLEVIPREX, SWAN CATHETER| CLEVIPREX, SWAN CATHETER