BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 7 FR X 20 CM

    MDR report key: 10088038 · Received May 26, 2020

    Report

    Report Number
    3006425876-2020-00489
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    April 24, 2020
    Report Date
    May 26, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED MULTIPLE COMPONENTS FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED COMPONENTS REVEALED THAT THE CATHETER OVER NEEDLE WAS RETURNED ATTACHED TO THE ARS, NOT THE INTRODUCER NEEDLE. THOUGH A CATHETER/NEEDLE CAN BE USED AS AN ALTERNATE TECHNIQUE, THE IFU STATES THE GUIDE WIRE WILL NOT PASS. IT IS UNCERTAIN IF THE CUSTOMER ATTEMPTED TO PASS THE GUIDE THROUGH THE CATHETER/NEEDLE OR IF IT WAS JUST RETURNED THIS WAY. VISUAL INSPECTION OF THE INTRODUCER NEEDLE REVEALED NO DEFECTS OR ANOMALIES. THE RETURNED GUIDE WIRE CONTAINED A SLIGHT KINK TOWARDS THE DISTAL END, AN ATTEMPT WAS MADE TO CONTACT THE CUSTOMER TO DETERMINE WHERE THE KINK OCCURRED. THE CUSTOMER RESPONDED THAT THEY WERE UNAWARE OF THE KINK, MAKING IT POSSIBLE THAT IT THE KINKED OCCURRED WHILE BE SHIPPED FOR INVESTIGATION. BOTH WELDS OF THE GUIDE WIRE APPEARED FULL AND SPHERICAL. NO OTHER DEFECTS WERE OBSERVED ON THE RETURNED COMPONENTS. THE KINK IN THE GUIDE WIRE MEASURED 21MM FROM THE DISTAL TIP. THE OVERALL LENGTH OF THE GUIDE WIRE MEASURED 602MM WHICH IS WITHIN SPECIFICATION OF 596-604MM PER PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDE WIRE MEASURED .796MM WHICH IS WITHIN SPECIFICATION OF .788-.826MM PER PRODUCT DRAWING. THE INNER DIAMETER OF THE INTRODUCER NEEDLE MEASURED .041" WHICH IS WITHIN SPECIFICATION OF .041-.043" PER PRODUCT DRAWING. THE RETURNED GUIDE WIRE PASSED THROUGH THE RETURNED ARS AND INTRODUCER NEEDLE WITH MINIMAL RESISTANCE. 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 WARNS THE USER "CATHETER/NEEDLE MAY BE USED IN THE STANDARD MANNER AS ALTERNATIVE TO INTRODUCER NEEDLE. IF CATHETER/NEEDLE IS USED, ARROW RAULERSON SYRINGE WILL FUNCTION AS A STANDARD SYRINGE, BUT WILL NOT PASS SPRING-WIRE GUIDE". SINCE IT IS UNCERTAIN IF THE CUSTOMER TRIED TO PASS THE GUIDE WIRE THROUGH THE CATHETER OVER NEEDLE, THE ROOT CAUSE OF THIS INVESTIGATION IS DEEMED UNDETERMINED. THE GUIDE WIRE WAS ABLE TO PASS THROUGH THE INTRODUCER NEEDLE WITH MINIMAL RESISTANCE. THE COMPLAINT THAT THE GUIDE WIRE COULD NOT PASS THROUGH THE NEEDLE WAS NOT CONFIRMED THROUGH THIS INVESTIGATION. THE CUSTOMER RETURNED A CATHETER OVER NEEDLE ATTACHED TO THE ARS. THE IFU STATES THAT THE GUIDE WIRE WILL NOT PASS THROUGH THE CATHETER OVER NEEDLE. HOWEVER, THE CUSTOMER ALSO RETURNED THE INTRODUCER NEEDLE MAKING IT UNCERTAIN WHICH NEEDLE WAS BEING USED WHEN TRYING TO PASS THE GUIDE WIRE. HOWEVER, THE RETURNED COMPONENTS PASSED OF RELEVANT DIMENSIONAL SPECIFICATIONS AND THE GUIDE WIRE WAS ABLE TO PASS THROUGH THE INTRODUCER NEEDLE WITH MINIMAL RESISTANCE. THE RETURNED GUIDE WIRE WAS RETURNED WITH A SLIGHT KINK TOWARDS THE DISTAL END, AN ATTEMPT WAS MADE TO CONTACT THE CUSTOMER TO DETERMINE WHERE THE KINK OCCURRED. THE CUSTOMER RESPONDED THAT THEY WERE UNAWARE OF THE KINK, MAKING IT POSSIBLE THAT IT THE KINKED OCCURRED WHILE BE SHIPPED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS COMPLETED BASED ON SALES HISTORY WITH NO RELEVANT FINDINGS. BECAUSE IT IS UNCLEAR WHICH NEEDLE WAS BEING USED, AND SINCE THE RETURNED INTRODUCER NEEDLE WAS FOUND WITH NO DEFECTS OR ANOMALIES, THE ROOT CAUSE OF THIS INVESTIGATION IS DEEMED UNDETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT DURING INSERTION THE GUIDE WIRE DID NOT ENTER TO THE NEEDLE WELL. THE MD COULD NOT PROCEED WITH THE PROCEDURE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    QN# (B)(4). THE PRELIMINARY EVALUATION OF THE RETURNED DEVICE INDICATES SWG/NEEDLE RESISTANCE - KINKED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT DURING INSERTION THE GUIDE WIRE DID NOT ENTER TO THE NEEDLE WELL. THE MD COULD NOT PROCEED WITH THE PROCEDURE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552015 ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN.| UNKNOWN.