BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM)

    MDR report key: 20212301 · Received September 13, 2024

    Report

    Report Number
    9680794-2024-00913
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 25, 2024
    Report Date
    August 26, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K002507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE, SHEATH EXTENSION ASSEMBLY FOR ANALYSIS. SIGNS OF USE WERE OBSERVED ON AND WITHIN THE DEVICE. VISUAL ANALYSIS DID NOT REVEAL ANY DEFECTS OR ANOMALIES WITH THE RETURNED DEVICE. THE SHEATH LENGTH FROM THE JUNCTURE HUB TO THE DISTAL TIP MEASURED 100 MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 97-103 MM PER SHEATH PRODUCT DRAWING. THE SHEATH BODY OUTER DIAMETER MEASURED 4.68 MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 4.59-4.71 MM PER SHEATH EXTRUSION PRODUCT DRAWING. SIMULATED USE OF THE SHEATH EXTENSION ASSEMBLY WAS PERFORMED PER THE PRODUCT INSTRUCTIONS-FOR-USE (IFU). A LAB INVENTORY SYRINGE FILLED WITH WATER WAS ATTACHED TO BOTH EXTENSION LINES AND FLUSHED. NO LEAKS OR BLOCKAGES WERE OBSERVED WHEN FLUSHING EITHER LUMEN. BOTH LUMENS FLUSHED AS INTENDED. THE HEMOSTASIS VALVE AND MAC DEVICE WERE LEAK TESTED ACCORDING TO THREE DIFFERENT PARAMETERS PER AMRQ-000038 REV.13. LOW PRESSURE LEAK RESISTANCE TEST (AMRQ-000038 SECTION 7.2.6): THIS STATES, "IF THE SHEATH INTRODUCER HAS AN INTEGRAL HEMOSTASIS VALVE, WHEN TESTED AS DESCRIBED IN ANNEX E OF BS EN ISO 11070, 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 SHEATH WAS ATTACHED TO THE LAB LEAK TESTER. WITH THE DISTAL END OF THE SHEATH OCCLUDED, EACH EXTENSION LINE ON THE SHEATH WAS INDIVIDUALLY PRESSURIZED TO 42 KPA FOR 30 SECONDS. NO LEAKS WERE OBSERVED, WHICH INDICATES THAT THE SHEATH VALVES ARE FUNCTIONING AS INTENDED. LIQUID LEAKAGE - HEMOSTASIS VALVE WITH CATHETER ADVANCED (AMRQ-000038 SECTION 7.2.7): THE PARAMETERS FROM THE LOW-PRESSURE LEAK RESISTANCE TEST WERE REPEATED WITH A LAB INVENTORY 7 FR SWAN-GANZ CATHETER INSERTED PAST THE SHEATH VALVES AND THE DISTAL END OF THE MAC OCCLUDED. EACH EXTENSION LINE ON THE SHEATH WAS INDIVIDUALLY PRESSURIZED TO 42 KPA FOR 30 SECONDS AND NO LEAKS WERE OBSERVED AT THE VALVES. NOTE: A MAC IS INTENDED FOR USE WITH 7-8 FR CATHETERS, BUT 7 FR CATHETER SIZE REPRESENTS A WORST-CASE SCENARIO FROM LIQUID LEAKAGE THROUGH HEMOSTASIS VALVE VIEWPOINT - CATHETERS WITH LARGER OUTER DIAMETER (7.5 OR 8 FR) BETTER OCCLUDE THE SEAL IN THE HEMOSTASIS VALVE. 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." THE SHEATH WAS ATTACHED TO THE LAB LEAK TESTER. WITH BOTH THE DISTAL END OF THE SHEATH AND THE HEMOSTASIS VALVE OCCLUDED, EACH EXTENSION LINE WAS PRESSURIZED TO 300 KPA FOR 30 SECONDS. NO LEAKS WERE DETECTED FROM ANY PORTION OF THE MAC, WHICH INDICATES THAT THE SHEATH ASSEMBLY IS INTACT, AND THE SHEATH VALVES ARE FUNCTIONING AS INTENDED. 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 PRODUCT LIDSTOCK WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE LIDSTOCK STATES, "MAC TWO-LUMEN CENTRAL VENOUS ACCESS KIT FOR USE WITH 7.5 - 8 FR. CATHETERS." THE REPORT OF A LEAKING CATHETER BODY WAS NOT CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. BOTH LUMENS PASSED FUNCTIONAL LEAK TESTING PERFORMED PER BS EN ISO 11070 AND NO EVIDENCE OF LEAKAGE, BACKFLOW, OR INTER LUMEN CROSSOVER WAS OBSERVED WITH ANY OF THE LUMENS. BASED ON THE CUSTOMER REPORT AND THE TESTING OF THE SAMPLE RECEIVED, NO PROBLEM WAS FOUND WITH THE RETURNED DEVICE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED "CATHETER LEAKING UNDER HUB WHEN BEING INFUSED. CATHETER WAS REPLACED WITH A NEW MULTI ACCESS CATHETER." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED "CATHETER LEAKING UNDER HUB WHEN BEING INFUSED. CATHETER WAS REPLACED WITH A NEW MULTI ACCESS CATHETER." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638347 ARROW MULTI LUMEN/PSI KIT: 9 FR X 4 IN (10 CM) CATHETER, INTRAVASCULAR, THER FOZ ARROW INTERNATIONAL LLC UNKNOWN

    Patients

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