BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW PICC KIT: 4 FR X 55 CM

    MDR report key: 22588418 · Received July 24, 2025

    Report

    Report Number
    3006425876-2025-00673
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    June 27, 2025
    Report Date
    June 30, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    LJS
    UDI-DI
    00801902092915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE PICC KIT FOR EVALUATION. THE KIT INCLUDED THE FOLLOWING COMPONENTS: NITINOL GUIDEWIRE, ADVANCER, TUBING, STYLET ASSEMBLY, CATHETER, SHEATH/DILATOR ASSEMBLY, CATHETER CLAMP, NEEDLE, AND SCALPEL. VISUAL INSPECTION OF THE NITINOL GUIDEWIRE REVEALED NO SIGNS OF DAMAGE OR ANOMALIES. HOWEVER, THE GUIDEWIRE FROM THE STYLET ASSEMBLY WAS FOUND TO BE UNRAVELED AND SEPARATED FROM THE DISTAL END. MICROSCOPIC EXAMINATION CONFIRMED THAT THE CORE WIRE WAS BROKEN ADJACENT TO THE DISTAL WELD. THE EXPOSED TIP OF THE DISTAL CORE WIRE APPEARED TAPERED AND DISCOLORED AT THE POINT OF SEPARATION. EVIDENCE OF BIOLOGICAL MATERIAL WAS PRESENT ON THE STYLET ASSEMBLY. THE RETURNED CATHETER SHOWED NO DEFINITE SIGNS OF USE OR VISIBLE DEFECTS OR ABNORMALITIES. IT HAD BEEN INTENTIONALLY TRIMMED BY THE CUSTOMER, AND BOTH TRIMMED SEGMENTS WERE INCLUDED IN THE RETURN. THE KINK IN THE GUIDEWIRE WAS MEASURED 220MM FROM THE PROXIMAL END. THE BROKEN CORE WIRE MEASURED 665MM IN LENGTH, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 26" - 27" PER STYLET PRODUCT DRAWING; THEREFORE, NO PIECES OF THE CORE WIRE APPEAR TO BE MISSING. THE OUTER DIAMETER OF THE GUIDEWIRE MEASURED 0.0157", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.0145" - 0.0165" PER GUIDEWIRE PRODUCT DRAWING. THE MEASURED LENGTH OF THE CATHETER FROM THE DISTAL END OF THE JUNCTURE HUB TO THE DISTAL TIP WAS 385 MM, WHICH FALLS OUTSIDE THE SPECIFIED RANGE OF 551.57 MM TO 556.35 MM AS DEFINED IN CATHETER PRODUCT DRAWING. HOWEVER, THE CATHETER HAD BEEN INTENTIONALLY TRIMMED BY APPROXIMATELY 167 MM. WHEN THIS TRIMMED PORTION IS ADDED TO THE REMAINING LENGTH, THE TOTAL CATHETER LENGTH IS APPROXIMATELY 552 MM, WHICH IS WITHIN THE SPECIFIED LIMITS. THE OUTER DIAMETER OF THE CATHETER BODY MEASURED 0.0551", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.054" - 0.057" PER CATHETER EXTRUSION PRODUCT DRAWING. FUNCTIONAL INSPECTION OF THE GUIDEWIRE COULD NOT BE PERFORMED FOR THIS COMPLAINT INVESTIGATION DUE TO THE DAMAGE TO THE RETURNED GUIDEWIRE. A LAB INVENTORY 0.46MM GUIDEWIRE PASSED THROUGH THE DISTAL EXTENSION LINE AND CATHETER BODY OF THE RETURNED CATHETER WITH MINIMAL RESISTANCE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS PRODUCT DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDEWIRE 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 GUIDEWIRE UNRAVELED WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE CORE WIRE WAS BROKEN ADJACENT TO THE DISTAL WELD. THE GUIDEWIRE MET ALL DIMENSIONAL REQUIREMENTS DURING INVESTIGATION TESTING, AND THE CATHETER MET ALL FUNCTIONAL/DIMENSIONAL REQUIREMENTS DURING INVESTIGATION TESTING. NO MANUFACTURING DEFECTS WERE FOUND DURING THIS INVESTIGATION. ARROW GUIDEWIRES OF THIS SIZE ARE DESIGNED AND MANUFACTURED TO WITHSTAND A TENSILE FORCE OF 1.5 POUNDS FORCE. THE SELECTED INSERTION SITE AND PATIENT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF GUIDEWIRE KINKING. GUIDEWIRE BREAKAGE MAY OCCUR IF A FORCE GREATER THAN THE DESIGN SPECIFICATION IS APPLIED DURING REMOVAL. BASED ON THESE CIRCUMSTANCES, UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "WHEN THE PLACER WAS GOING TO USE THE GUIDEWIRE DURING THE PICC PLACEMENT PROCEDURE, HE NOTICED THAT THE WIRE WAS BROKEN. HE THEN OPENED A NEW SET AND THE PICC GOT PLACED. NO FURTHER COMPLICATIONS HAVE BEEN MENTIONED." ADDITIONAL INFORMATION RECEIVED STATES "THE GUIDEWIRE UNRAVELED WHEN WITHDRAWING FROM THE PICC". THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "WHEN THE PLACER WAS GOING TO USE THE GUIDEWIRE DURING THE PICC PLACEMENT PROCEDURE, HE NOTICED THAT THE WIRE WAS BROKEN. HE THEN OPENED A NEW SET AND THE PICC GOT PLACED. NO FURTHER COMPLICATIONS HAVE BEEN MENTIONED." ADDITIONAL INFORMATION RECEIVED STATES "THE GUIDEWIRE UNRAVELED WHEN WITHDRAWING FROM THE PICC". THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188409 ARROW PICC KIT: 4 FR X 55 CM CATHETER, INTRAVASCULAR, THERAPEUTIC LJS ARROW INTERNATIONAL LLC IPN919401 71F25B0997 00801902092915

    Patients

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