BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTI-LUMEN/PSI KIT

    MDR report key: 12869033 · Received November 24, 2021

    Report

    Report Number
    9680794-2021-00614
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    October 18, 2021
    Report Date
    November 8, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE MULTI-LUMEN PSI CATHETER FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED. NO OBVIOUS DEFECTS OR ANOMALIES WERE FOUND ON THE CATHETER. THE SHEATH LENGTH MEASURED 99MM WHICH IS WITHIN THE SPECIFICATION LIMITS OF 98MM-102MM PER THE SHEATH GRAPHIC. THE OUTER DIAMETER OF THE CATHETER BODY MEASURED TO BE .1826" WHICH IS WITHIN SPECIFICATIONS OF .1805"-.1855" PER THE SHEATH EXTRUSION GRAPHIC. A HIGH-PRESSURE TEST WAS PERFORMED WITH THE RETURNED OBTURATOR OCCLUDING THE HEMOSTASIS VALVE. PER APPENDIX D OF BS EN ISO 11070, THE SHEATH EXTENSION LINES WERE CONNECTED TO A LEAK TESTER. WITH THE DISTAL END OF THE SHEATH OCCLUDED, THE SHEATH WAS PRESSURIZED TO 300KPA FOR 30 SECONDS. NO LEAKS OR DEFECTS WERE OBSERVED. A LOW-PRESSURE TEST WAS PERFORMED IN ORDER TO ANALYZE THE VALVES OF THE SHEATH ASSEMBLY. A FUNCTIONAL LEAK TEST WAS PERFORMED PER AMRQ-000038 SECTION 7.2.6 REV. 06. A LAB INVENTORY 8FR SWANN-GANZ CATHETER WAS INSERTED THROUGH THE VALVES. THE SHEATH EXTENSION LINES WERE THEN CONNECTED TO A LEAK TESTER. THE ASSEMBLY WAS PRESSURIZED TO 40KPA AND MAINTAINED FOR 30 SECONDS. NO LEAKS WERE DETECTED FROM THE HEMOSTASIS VALVE. A SECOND LOW-PRESSURE TEST WAS PERFORMED IN ORDER TO ANALYZE THE VALVES OF THE SHEATH ASSEMBLY. A FUNCTIONAL LEAK TEST WAS PERFORMED PER AMRQ-000038 SECTION 7.2.6 REV. 06. THE SHEATH EXTENSION LINES WERE THEN CONNECTED TO A LEAK TESTER. WITH THE DISTAL END OF THE SHEATH OCCLUDED, THE ASSEMBLY WAS PRESSURIZED TO 40KPA AND MAINTAINED FOR 30 SECONDS. NO LEAKS WERE DETECTED FROM THE HEMOSTASIS VALVE. 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 IFU PROVIDED WITH THIS KIT PRECAUTIONS THE USER, "DO NOT SUTURE DIRECTLY TO THE OUTSIDE DIAMETER OF THE CATHETER TO MINIMIZE THE RISK OF CUTTING OR DAMAGING THE CATHETER OR IMPEDING CATHETER FLOW. DO NOT PLACE STAPLE OVER ACCESS DEVICE BODY OR EXTENSION LINES EXCEPT AT INDICATED ANCHORING LOCATION TO MINIMIZE THE RISK OF DAMAGE TO ACCESS DEVICE. TO MINIMIZE THE RISK OF CUTTING ACCESS DEVICE, DO NOT USE SCISSORS TO REMOVE DRESSING." THE IFU ALSO CONTAINS THE WARNING "HEMOSTASIS VALVE MUST BE OCCLUDED AT ALL TIMES TO MINIMIZE THE RISK OF AIR EMBOLISM OR HEMORRHAGE." THE CUSTOMER REPORT OF A CATHETER LEAK WAS UNABLE TO BE CONFIRMED BY FUNCTIONAL TESTING OF THE RETURNED CATHETER. THE CATHETER PASSED BOTH A HIGH-PRESSURE AND TWO LOW PRESSURE TESTS (PER BS EN ISO 11070). NO LEAKS WERE OBSERVED FROM ANY PART OF THE SHEATH ASSEMBLY. THE SAMPLE PASSED ALL RELEVANT DIMENSIONAL TESTING, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE SAMPLE RECEIVED, NO PROBLEM WAS FOUND. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    QN#: (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTS CATHETER LEAKING WHERE THE BLUE ANCHOR IS SUTURED IN. THERE WAS NO INJURY TO PATIENT, BUT THERAPY WAS DELAYED AS THE CATHETER HAD TO BE REMOVED AND REPLACED WITH A PERIPHERAL OR TRIPLE LUMEN. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    CUSTOMER REPORTS CATHETER LEAKING WHERE THE BLUE ANCHOR IS SUTURED IN. THERE WAS NO INJURY TO PATIENT, BUT THERAPY WAS DELAYED AS THE CATHETER HAD TO BE REMOVED AND REPLACED WITH A PERIPHERAL OR TRIPLE LUMEN. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769607 ARROW MULTI-LUMEN/PSI KIT CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL INC. UNKNOWN

    Patients

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