BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 7 FR X 16 CM

    MDR report key: 7406696 · Received April 9, 2018

    Report

    Report Number
    3006425876-2018-00219
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Date of Event
    March 1, 2018
    Report Date
    March 23, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED A GUIDE WIRE ASSEMBLY, A 3-LUMEN CATHETER AND THE PRODUCT LID STOCK FOR EVALUATION. THE GUIDE WIRE WAS SEPARATED INTO TWO PIECES. THE COMPONENTS SHOWED EVIDENCE OF USE IN THE FORM OF DRIED BLOOD. VISUAL EXAMINATION REVEALED THE GUIDE WIRE IS SEPARATED FROM THE DISTAL WELD AND IS KINKED/DISTORTED IN SEVERAL LOCATIONS ALONG THE BODY. THE CORE WIRE DISTAL J-BEND WAS EXPOSED OUT OF THE COIL WIRE INDICATING THE CORE WIRE BROKE AT THE DISTAL WELD. THE COIL WIRE WAS ALSO BROKEN AND THE DISTAL COIL WIRE HAD SEPARATED. THE RETURNED CATHETER SHOWED EVIDENCE OF USE BUT NO OBVIOUS DEFECTS OR ANOMALIES. MICROSCOPIC EXAMINATION OF THE GUIDE WIRE CONFIRMED THE CORE WIRE WAS BROKEN ADJACENT TO THE DISTAL WELD. THE EXPOSED DISTAL CORE WIRE TIP IS TAPERED AND DISCOLORED AT THE POINT OF SEPARATION. BOTH WELDS WERE PRESENT AND APPEARED FULL AND SPHERICAL. THE SEPARATION POINTS OF THE COIL WIRE WERE SMOOTH AND BLUNT LIKELY INDICATING CONTACT WITH A SHARP INSTRUMENT (I.E. SCALPEL, SCISSORS, ETC.) MICROSCOPIC EXAMINATION OF THE CATHETER DID NOT REVEAL ANY DEFECTS OR ANOMALIES. THE MAJOR KINKS IN THE GUIDE WIRE BODY WERE MEASURED AT 71, 210, 234, 281 AND 311 MM FROM THE PROXIMAL WELD. THE BROKEN CORE WIRE MEASURED 455 MM IN LENGTH, WHICH IS WITHIN SPECIFICATION; THEREFORE NO PIECES OF THE CORE WIRE APPEAR TO BE MIS SING. THE OUTSIDE DIAMETER OF THE GUIDE WIRE AND THE CATHETER BODY LENGTH WERE MEASURED AND BOTH WERE FOUND TO BE WITHIN SPECIFICATION. A LAB INVENTORY GUIDE WIRE OF SAME DIAMETER AS THAT SUPPLIED IN KIT CV-12703 PASSED THROUGH THE DISTAL EXTENSION LINE AND CATHETER BODY OF THE RETURNED CATHETER WITH MINIMAL RESISTANCE. A MANUAL TUG TEST CONFIRMED THAT THE PROXIMAL WELD WAS INTACT. A DEVICE HISTORY RECORD 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 2-3 CM 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 SEPARATED WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE CORE WIRE WAS BROKEN ADJACENT TO THE DISTAL WELD. THE GUIDE WIRE AND CATHETER MET ALL FUNCTIONAL/DIMENSIONAL REQUIREMENTS DURING INVESTIGATION TESTING. NO MANUFACTURING DEFECTS WERE FOUND DURING THIS INVESTIGATION. ARROW GUIDE WIRES OF THIS SIZE ARE DESIGNED AND MANUFACTURED TO WITHSTAND A TENSILE FORCE OF 2.75 POUNDS FORCE. THIS INTERNAL SPECIFICATION IS HIGHER THAN THE BS EN ISO 11070:2014 STANDARD OF 2.2 POUNDS FORCE FOR THIS SIZE WIRE. THE SELECTED INSERTION SITE AND PATIENT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF GUIDE WIRE KINKING. GUIDE WIRE BREAKAGE MAY OCCUR IF A FORCE GREATER THAN THE DESIGN SPECIFICATION IS APPLIED DURING REMOVAL. BASED ON THESE CIRCUMSTANCES IT WAS DETERMINED THAT OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: DURING INSERTION, THE SHEATH OF THE SWG GOT CUT INSIDE THE VEIN. THIS WAS OBSERVED ON AN X RAY. INTERVENTION: THE PATIENT HAD TO GO BACK TO THE SURGERY ROOM TO REMOVE THE GUIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: DURING INSERTION, THE SHEATH OF THE SWG GOT CUT INSIDE THE VEIN. THIS WAS OBSERVED ON AN X RAY. INTERVENTION: THE PATIENT HAD TO GO BACK TO THE SURGERY ROOM TO REMOVE THE GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250517 ARROW CVC SET: 3-LUMEN 7 FR X 16 CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F18A1427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention