BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 16 GA X 8" (20 CM)

    MDR report key: 6843164 · Received September 5, 2017

    Report

    Report Number
    3006425876-2017-00379
    Event Type
    Malfunction
    Date Received
    September 5, 2017
    Date of Event
    August 21, 2017
    Report Date
    August 24, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    QN# (B)(4). THE CUSTOMER RETURNED AN OPENED ES-04301 SET WITH VARIOUS COMPONENTS INCLUDING A SPRING WIRE GUIDE (SWG) ASSEMBLY, AN ARROW RAULERSON SYRINGE (ARS), AN INTRODUCER NEEDLE AND A SINGLE LUMEN CATHETER. THE GUIDE WIRE WAS RETURNED RETRACTED WITHIN THE ADVANCER TUBE AND EACH OF THE COMPONENTS SHOWED EVIDENCE OF USE. VISUAL EXAMINATION REVEALED THE GUIDE WIRE WAS KINKED IN SEVERAL LOCATIONS TOWARDS THE DISTAL END OF THE BODY. THE DISTAL J-BEND WAS DEFORMED BUT INTACT. ALTHOUGH SIGNIFICANT DRIED BLOOD WAS REMOVED FROM THE ARS, INTRODUCER NEEDLE AND CATHETER; NO OBVIOUS DAMAGE OR ANOMALIES WERE OBSERVED. MICROSCOPIC EXAMINATION CONFIRMED THE KINKS IN THE GUIDE WIRE BODY INCLUDING OFFSET COILS IN SEVERAL LOCATIONS. BOTH WELDS WERE PRESENT AND OBSERVED TO BE FULL AND SPHERICAL. NO DAMAGE OR ANOMALIES WERE OBSERVED ON ANY OF THE OTHER COMPONENTS. THE KINKS IN THE GUIDE WIRE BODY WERE MEASURED AT 36, 64, 92, 121, 187, 206 AND 584MM FROM THE DISTAL TIP. THE GUIDE WIRE OVERALL LENGTH AND OUTER DIAMETER WERE MEASURED AND WERE FOUND TO BE WITHIN SPECIFICATION. (CON'T) OTHER REMARKS: THE INTRODUCER NEEDLE CANNULA INNER DIAMETER, THE CATHETER BODY LENGTH, AND THE CATHETER EXTENSION LINE LENGTH WERE MEASURED AND ALL WERE FOUND TO BE WITHIN SPECIFICATION. A LAB INVENTORY 0.032" SWG WAS ADVANCED THROUGH THE RETURNED INSERTION COMPONENTS (ARS AND INTRODUCER NEEDLE) WITH MINIMAL RESISTANCE. THE CATHETER WAS ADVANCED OVER THE SAME GUIDE WIRE WITH MINIMAL RESISTANCE. A MANUAL TUG TEST CONFIRMED THAT BOTH THE DISTAL AND PROXIMAL WELDS WERE INTACT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE GUIDE WIRE AND CATHETER AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THIS PRODUCT DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. THE IFU CAUTIONS THAT IF RESISTANCE IS ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE SPRING-WIRE GUIDE AFTER CATHETER PLACEMENT, THE SPRING-WIRE MAY BE KINKED ABOUT THE TIP OF THE CATHETER WITHIN THE VESSEL WHICH MAY RESULT IN UNDUE FORCE BEING APPLIED RESULTING IN SPRING-WIRE GUIDE BREAKAGE. IF RESISTANCE IS ENCOUNTERED, WITHDRAW THE CATHETER RELATIVE TO THE SPRING-WIRE GUIDE ABOUT 2-3CM AND ATTEMPT TO REMOVE THE SPRING-WIRE GUIDE. IF RESISTANCE IS AGAIN ENCOUNTERED, REMOVE THE SPRING-WIRE GUIDE AND CATHETER SIMULTANEOUSLY. THE REPORT THAT THE GUIDE WIRE KINKED DURING USE WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE GUIDE WIRE WAS KINKED IN SEVERAL LOCATIONS ALONG THE BODY. THE RETURNED GUIDE WIRE, INSERTION COMPONENTS (ARS & INTRODUCER NEEDLE) AND CATHETER MET ALL RELEVANT DIMENSIONAL/FUNCTIONAL REQUIREMENTS AND A DHR REVIEW DID NOT IDENTIFY ANY MANUFACTURING RELATED ISSUES. BASED ON THE CONDITION OF THE GUIDE WIRE AND THE REPORT THAT THE DAMAGE WAS OBSERVED DURING USE, IT WAS DETERMINED THAT OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE DOCTOR FOUND THE GUIDE WIRE KINKED DURING THE CATHETER INSERTION. A DELAY IN THERAPY REPORTED. ANOTHER DEVICE WAS USED. NO PATIENT INJURY OR COMPLICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE DOCTOR FOUND THE GUIDE WIRE KINKED DURING THE CATHETER INSERTION. A DELAY IN THERAPY REPORTED. ANOTHER DEVICE WAS USED. NO PATIENT INJURY OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622247 ARROW CVC SET: 16 GA X 8" (20 CM) CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F15H0703

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR