BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTILUMEN/PSI KIT 9 FR X 11.5 CM

    MDR report key: 18693395 · Received February 13, 2024

    Report

    Report Number
    9680794-2024-00170
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 17, 2024
    Report Date
    January 17, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    10801902112054
    PMA / PMN Number
    K011761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE MAC CATHETER FOR ANALYSIS. IT WAS OBSERVED THAT THE OBTURATOR COMPONENT WAS INSERTED OVER THE HEMOSTASIS CAP. SIGNS OF USE IN THE FORM OF BIOMATERIAL WERE OBSERVED. VISUAL ANALYSIS OF THE MAC BODY DID NOT REVEAL ANY OBVIOUS DEFECTS OR ANOMALIES. LIKEWISE, ANALYSIS DOWN THE PROXIMAL OPENING OF THE HEMOSTASIS CAP DID NOT REVEAL ANY DEFECTS WITH THE INTERNAL VALVE. THE OUTER DIAMETER OF THE DISTAL EXTENSION LINE MEASURED 4.79MM WHICH IS WITHIN THE SPECIFICATION LIMITS OF 4.70MM-4.80MM PER THE DISTAL EXTENSION LINE EXTRUSION PRODUCT DRAWING. THE INNER DIAMETER OF THE DISTAL EXTENSION LINE MEASURED 2.9718MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 2.90MM-3.00MM PER THE DISTAL EXTENSION LINE EXTRUSION PRODUCT DRAWING. THE OUTER DIAMETER OF THE PROXIMAL EXTENSION LINE MEASURED 2.91MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 2.90MM-3.00MM PER THE PROXIMAL EXTENSION LINE EXTRUSION PRODUCT DRAWING. THE INNER DIAMETER OF THE DISTAL EXTENSION LINE MEASURED 2.1336MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 2.11MM-2.21MM PER THE PROXIMAL EXTENSION LINE EXTRUSION PRODUCT DRAWING. THE VALVE AND MAC DEVICE WERE LEAK TESTED ACCORDING TO THREE DIFFERENT PARAMETERS PER BS EN ISO 11070 DEFINED IN AMRQ-000038 REV12. 1) LOW PRESSURE LEAK RESISTANCE TEST (AMRQ-000038 SECTION 6.1.2): THIS STATES, "USING A TEST PRESSURE OF 38-42KPA (5.51-6.09PSI), THERE SHALL BE NO LEAKAGE PAST THE HEMOSTASIS VALVE." THE PSI 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 A LAB INVENTORY 7FR 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 6.1.3): THIS STATES, "WHEN TESTED IN ACCORDANCE WITH ISO 11070:, ANNEX D, USING A TEST PRESSURE OF 300-320 KPA (43.5 - 46.4 PSI) THERE SHALL BE NO LEAKAGE SUFFICIENT TO FORM A FALLING DROP." WITH BOTH THE DISTAL END OF THE SHEATH AND THE HEMOSTASIS VALVE OCCLUDED, THE DEVICE WAS PRESSURIZED TO 300KPA FOR 30SECONDS. NO LEAKS WERE DETECTED FROM ANY PORTION OF THE PSI, WHICH INDICATES THAT THE ASSEMBLY IS INTACT. NO BACKFLOW ACROSS EXTENSION LINES OR INTER-LUMEN CROSSOVER WAS OBSERVED DURING FUNCTIONAL TESTING. A MANUAL TUG TEST CONFIRMED THAT THE EXTENSION LINES WERE 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 TAKEN FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. THE LIDSTOCK PRODUCT DRAWING WAS ALSO REVIEWED AS PART OF THIS COMPLAINT INVESTIGATION. IT WAS CONFIRMED THAT THE REPORTED MAC CATHETER IS COMPATIBLE WITH 7-7.5 FR CATHETERS, WHICH MATCHES THE INSERTED CVC THAT WAS RETURNED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT SUTURE DIRECTLY TO THE OUTSIDE DIAMETER OF ACCESS DEVICE TO MINIMIZE THE RISK OF CUTTING OR DAMAGING DEVICE OR IMPEDING DEVICE FLOW". THE CUSTOMER REPORT OF A LEAKING CATHETER COULD NOT BE CONFIRMED THROUGH INVESTIGATION OF THE RETURNED SAMPLE. THE RETURNED MAC PASSED ALL RELEVANT DIMENSIONAL AND FUNCTIONAL REQUIREMENTS INCLUDING LEAK TESTING PERFORMED PER ISO 11070. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON A POTENTIAL LOT# OBTAINED FROM SALES HISTORY AND NO RELEVANT FINDINGS WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: L IJ SITE IS LEAKING. BOTH LUMENS OF THE INTRODUCER ARE OCCLUDED AND 1 LUMEN OF THE CLIP-IN IS OCCLUDED. THE PHYSICIAN WAS ABLE TO FLUSH THE BROWN LUMEN AND CLEAR FLUID LEAKED OUT OF THE SKIN-CATHETER SITE. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "UNKNOWN". SHOULD FURTHER DETAILS BE PROVIDED, THE COMPLAINT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: L IJ SITE IS LEAKING. BOTH LUMENS OF THE INTRODUCER ARE OCCLUDED AND 1 LUMEN OF THE CLIP-IN IS OCCLUDED. THE PHYSICIAN WAS ABLE TO FLUSH THE BROWN LUMEN AND CLEAR FLUID LEAKED OUT OF THE SKIN-CATHETER SITE. THE REPORTED DEFECT WAS DETECTED DURING USE ON PATIENT. THE PATIENT CONDITION WAS REPORTED AS "UNKNOWN". SHOULD FURTHER DETAILS BE PROVIDED, THE COMPLAINT WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136923 ARROW MULTILUMEN/PSI KIT 9 FR X 11.5 CM CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL LLC UNKNOWN 10801902112054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED| NOT REPORTED