BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTI-LUMEN/PSI KIT

    MDR report key: 20333454 · Received September 30, 2024

    Report

    Report Number
    9680794-2024-00968
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 6, 2024
    Report Date
    September 9, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K002507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE MULTI-LUMEN PERCUTANEOUS SHEATH INTRODUCER (MAC) FOR ANALYSIS. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED ON THE RETURNED DEVICE. NEITHER THE DILATOR NOR THE OBTURATOR WAS RETURNED FOR ANALYSIS. IT WAS NOTED THAT A BLACK CAP WAS PLACED OVER THE HEMOSTASIS BODY. THIS CAP RESEMBLES A SEAL OF A SYRINGE; HOWEVER, IT IS UNKNOWN IF THIS IS FROM ONE OF THE SYRINGES INCLUDED WITHIN THIS KIT. VISUAL ANALYSIS OF THE RETURNED MAC DID NOT REVEAL ANY DEFECTS OR ANOMALIES. THE HEMOSTASIS VALVE AND MAC WERE LEAK TESTED ACCORDING TO THREE DIFFERENT PARAMETERS PER AMRQ-000038 REV 13. 1.) LOW PRESSURE LEAK RESISTANCE TEST (AMRQ-000038 SECTION 7.2.6): THIS STATES, "WHEN TESTED IN ACCORDANCE WITH ISO 11070: ANNEX E, USING A TEST PRESSURE OF 38-42KPA (5.51-6.09PSI), THERE SHALL BE NO LEAKAGE PAST THE HEMOSTASIS VALVE." THE PSI WAS ATTACHED TO A LAB LEAK TESTER WITH THE DISTAL END OF THE SHEATH OCCLUDED AND PRESSURIZED TO 42KPA FOR 30 SECONDS. NO LEAKS WERE DETECTED FROM THE HEMOSTASIS VALVE, WHICH INDICATES THAT THE VALVES ARE FUNCTIONAL AND INTACT. 2.) HIGH PRESSURE LEAK RESISTANCE TEST (AMRQ-000038 SECTION 7.2.5): THIS STATES, "WHEN TESTED IN ACCORDANCE WITH ISO 11070: ANNEX E, USING A TEST PRESSURE OF 300-320KPA (43.5-46.4PSI), THERE SHALL BE NO LEAKAGE SUFFICIENT FOR FORM A FALLING DROP." THE MAC EXTENSION LINES WERE INDIVIDUALLY ATTACHED TO THE LAB LEAK TESTER. WITH THE DISTAL END OF THE SHEATH OCCLUDED AND A LAB INVENTORY OBTURATOR OVER THE HEMOSTASIS BODY, THE MAC WAS PRESSURIZED TO 300KPA FOR 30 SECONDS. NO LEAKS WERE DETECTED FROM ANY PORTION OF THE PSI, WHICH INDICATES THAT THE SHEATH ASSEMBLY IS INTACT. 3.) LIQUID LEAKAGE - HEMOSTASIS VALVE WITH A CATHETER INSERTED: A LAB INVENTORY 7FR SWAN-GANZ WAS INSERTED INTO THE VALVE OF THE SHEATH. THE SHEATH WAS THEN PRESSURIZED TO 42KPA FOR 30 SECONDS. NO LEAK WAS OBSERVED. A LAB INVENTORY 0.085" PIN GAGE WAS INSERTED INTO THE VALVE. THE MAC BODY WAS PLACED INTO A BEAKER FILLED WITH WATER. A LAB INVENTORY SYRINGE WAS THEN ATTACHED TO THE DISTAL LINE. THE SYRINGE WAS ASPIRATED, AND NO AIR BUBBLES WERE OBSERVED. THE MAC APPEARS TO ASPIRATE AS INTENDED. THE TEST ABOVE WAS REPEATED WITH THE PIN GAGE HELD AT A SLIGHT ANGLE. UPON ASPIRATION, AIR BUBBLES WERE OBSERVED. THEREFORE, THE REPORTED EVENT WAS ABLE TO BE RE-CREATED. R & D WAS CONTACTED AS PART OF THIS COMPLAINT. THEY CONFIRMED THAT MACS OF THIS TYPE ARE DESIGNED TO BE COMPATIBLE WITH ALL TYPES OF CATHETERS; HOWEVER, THE ORIENTATION OF THE INSERTED CATHETER CAN POSSIBLY AFFECT THE FUNCTIONALITY OF THE INTERNAL VALVE. IT IS RECOMMENDED THAT THE CATHETER BE KEPT IN A STRAIGHT POSITION WHILE INSERTED IN THE SHEATH. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER TAKEN FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "USE ARROW OBTURATOR, EITHER INCLUDED WITH THIS PRODUCT OR SOLD SEPARATELY, TO OCCLUDE HEMOSTASIS VALVE ASSEMBLY. THIS WILL ENSURE THAT LEAKAGE DOES NOT OCCUR , AND INNER SEAL IS PROTECTED FROM CONTAMINATION". THE REPORT OF A LEAKING VALVE DURING ASPIRATION WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED SAMPLE. FUNCTIONAL LEAK TESTING OF THE DEVICE IN ACCORDANCE WITH BS EN ISO 11070 DID NOT REVEAL ANY LEAKS OR ANOMALIES OF ANY KIND; HOWEVER, ASPIRATION TESTING REVEALED THAT AIR-BUBBLES FORM WHEN THE INSERTED COMPONENT IS HELD AT AN ANGLE. CONSULTATION FROM R & D REVEALED ANGLED CATHETERS CAN CONTRIBUTE TO THE CUSTOMER OBSERVING AIR-BUBBLES DURING ASPIRATING. THE INSERTED CATHETER SIZE AND THE ORIENTATION AT THE TIME OF THE REPORTED EVENT ARE UNKNOWN; THEREFORE , THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED "NURSES WITHDREW AIR FROM THE RIGHT INTERNAL JUGULAR CORDIS. CONCERNED AIR IS LEAKING THROUGH." THERE WAS NO PATIENT HARM. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED "NURSES WITHDREW AIR FROM THE RIGHT INTERNAL JUGULAR CORDIS. CONCERNED AIR IS LEAKING THROUGH." THERE WAS NO PATIENT HARM. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2587986 ARROW MULTI-LUMEN/PSI KIT INTRODUCER CATHETER FOZ ARROW INTERNATIONAL LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NONE REPORTED| NONE REPORTED