BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW RA CATH SET: 20 GA X 1-1/2"

    MDR report key: 11301622 · Received February 9, 2021

    Report

    Report Number
    9680794-2021-00067
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    November 30, 2020
    Report Date
    February 9, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQX
    UDI-DI
    00801902002761
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE OPENED RA SET FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED SAMPLE DID NOT REVEAL ANY DEFECTS OR ANOMALIES. THE GUIDE WIRE DID NOT CONTAIN ANY KINKS OR BENDS. THE TOTAL LENGTH OF THE GUIDE WIRE MEASURED TO BE 115 MM WHICH IS WITHIN SPECIFICATIONS OF 113-117 MM PER PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDE WIRE MEASURED TO BE 0.443 MM WHICH IS WITHIN SPECIFICATIONS OF 0.432-0.457 MM PER PRODUCT DRAWING. THE RETURNED GUIDE WIRE WAS ABLE TO FULLY ADVANCE THROUGH THE RETURNED INTRODUCER NEEDLE. THE CATHETER WAS THEN ABLE TO FULLY DEPLOY OFF THE NEEDLE/SWG ASSEMBLY. A MANUAL TUG TEST CONFIRMED THE DISTAL WELD WAS FULLY INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THE IFU PROVIDED WITH THIS KIT CAUTIONS THE USER, "IF RESISTANCE IS ENCOUNTERED WHILE ADVANCING SPRING-WIRE GUIDE DO NOT FORCE FEED. WARNING: DO NOT RETRACT SPRING-WIRE GUIDE AGAINST EDGE OF NEEDLE WHILE IN VESSEL TO MINIMIZE THE RISK OF SPRING-WIRE GUIDE DAMAGE." THE CUSTOMER REPORT OF A DAMAGED GUIDE WIRE COULD NOT BE CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE GUIDE WIRE PASSED ALL RELEVANT VISUAL, DIMENSIONAL, AND FUNCTIONAL TESTING, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. NO PROBLEM WAS FOUND. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: THE SPRING WIRE GUIDE WAS "UNRAVELED" PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT REPORTED.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: THE SPRING WIRE GUIDE WAS "UNRAVELED" PRIOR TO PATIENT USE. NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200350 ARROW RA CATH SET: 20 GA X 1-1/2" WIRE GUIDE CATHETER DQX ARROW INTERNATIONAL INC. IPN035916 14F19L0289 00801902002761

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A.