BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS KIT: 2-L 14 FR X 20 CM ANTI

    MDR report key: 7293311 · Received February 23, 2018

    Report

    Report Number
    1036844-2018-00080
    Event Type
    Malfunction
    Date Received
    February 23, 2018
    Date of Event
    February 12, 2018
    Report Date
    February 12, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED A SINGLE UNRAVELED GUIDE WIRE FOR EVALUATION. THE CATHETER WAS NOT RETURNED. THE GUIDE WIRE WAS UNRAVELED AND SHOWED EVIDENCE OF USE IN THE FORM OF DRIED BLOOD. VISUAL EXAMINATION REVEALED THE GUIDE WIRE IS UNRAVELED FROM THE DISTAL WELD AND IS KINKED/DISTORTED IN SEVERAL LOCATIONS ALONG THE BODY. THE CORE WIRE DISTAL J-BEND WAS DEFORMED AND EXPOSED OUT OF THE COIL WIRE. THE DISTAL QUARTER LENGTH OF THE CORE WIRE IS NOT KINKED BUT IS DEFORMED INTO A CURLED/LOOPED SHAPE. MICROSCOPIC EXAMINATION OF THE GUIDE WIRE CONFIRMED THE CORE WIRE WAS BROKEN ADJACENT TO THE DISTAL WELD AND THAT THE WELD WAS PRESENT AT THE END OF THE COIL WIRE. THE EXPOSED DISTAL CORE WIRE TIP TAPERED AND DISCOLORED AT THE POINT OF SEPARATION. BOTH WELDS APPEARED FULL AND SPHERICAL. VISUAL INSPECTION OF THE CATHETER COULD NOT BE PERFORMED AS THE CATHETER WAS NOT RETURNED. THE MAJOR KINKS IN THE GUIDE WIRE BODY WERE MEASURED AT 210, 354, 359, 397 MM FROM THE PROXIMAL TIP. THE GUIDE WIRE BODY WAS CURLED/LOOPED FROM 397 MM TO THE DISTAL TIP OF THE CORE WIRE. THE BROKEN CORE WIRE MEASURED 599 MM IN LENGTH, WHICH IS WITHIN SPECIFICATION; THEREFORE NO PIECES OF THE CORE WIRE APPEAR TO BE MISSING. THE OUTSIDE DIAMETER OF THE GUIDE WIRE WAS ALSO WITHIN SPECIFICATION. (CON'T) OTHER REMARKS: THE UNDAMAGED PROXIMAL END OF THE GUIDE WIRE WAS ADVANCED THROUGH A LAB INVENTORY 18GA INTRODUCER NEEDLE AND ARS AND PASSED THROUGH BOTH COMPONENTS 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 WAS UNRAVELED WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE GUIDE WIRE CORE WIRE WAS BROKEN ADJACENT TO THE DISTAL WELD. DIMENSIONAL INSPECTION AND A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY EVIDENCE OF A MANUFACTURING RELATED ISSUE. 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, OPERATIONAL CONTEXT LIKELY CONTRIBUTED TO THIS EVENT, HOWEVER, THE PROBABLE CAUSE OF GUIDE WIRE AND CATHETER RESISTANCE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE CATHETER BEING RETURNED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS: GUIDEWIRE WHEN IN THE CATHETER WAS BEING INSERTED, THEN PULLED ON WITH TOO MUCH FORCE, IT UNRAVELED". THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT CONDITION IS REPORTED AS "FINE". THERAPY WAS NOT DELAYED/INTERRUPTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS: GUIDEWIRE WHEN IN THE CATHETER WAS BEING INSERTED, THEN PULLED ON WITH TOO MUCH FORCE, IT UNRAVELED". THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT CONDITION IS REPORTED AS "FINE". THERAPY WAS NOT DELAYED/INTERRUPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135303 ARROW HEMODIALYSIS KIT: 2-L 14 FR X 20 CM ANTI CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL INC. 23F17H0748

    Patients

    Seq Age Sex Outcome Treatment
    1