BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM

    MDR report key: 6846003 · Received September 6, 2017

    Report

    Report Number
    3006425876-2017-00388
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    August 20, 2017
    Report Date
    August 25, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE CUSTOMER RETURNED ONE GUIDE WIRE FOR EVALUATION. THE CATHETER WAS NOT RETURNED. THE GUIDE WIRE WAS UNRAVELED AND SHOWED EVIDENCE OF USE. VISUAL EXAMINATION REVEALED THE GUIDE WIRE IS UNRAVELED FROM THE PROXIMAL WELD AND HAS MULTIPLE KINKS IN THE GUIDE WIRE BODY. THE DISTAL J-BEND IS UNDAMAGED. MICROSCOPIC EXAMINATION OF THE GUIDE WIRE CONFIRMED THE CORE WIRE WAS BROKEN ADJACENT TO THE PROXIMAL WELD AND THAT THE WELD WAS PRESENT AT THE END OF THE COIL WIRE. THE EXPOSED PROXIMAL CORE WIRE TIP IS ROUNDED AND PINCHED AT THE POINT OF SEPARATION. BOTH WELDS APPEARED FULL AND SPHERICAL. THE MAJOR KINKS IN THE GUIDE WIRE BODY WERE MEASURED AT 96, 161, 194, 206, 215, 227, 241 AND 275 MM FROM THE DISTAL TIP. THE BROKEN CORE WIRE MEASURED 680MM IN LENGTH, WHICH IS WITHIN SPECIFICATION; THEREFORE NO PIECES OF THE CORE WIRE APPEAR TO BE MISSING. THE OUTER DIAMETER OF THE GUIDE WIRE WAS MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATION. A MANUAL TUG TEST CONFIRMED THAT THE DISTAL WELD WAS INTACT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE GUIDE WIRE AND THE CATHETER AND NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. (CON'T) OTHER REMARKS: 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 PROXIMAL WELD. DIMENSIONAL INSPECTION AND A DHR 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 11070:1999 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 MOST 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED REGARDING THIS EVENT AND PATIENT CONDITION/INJURY. NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE INSERTION WAS SUCCESSFUL, THE ISSUE HAPPENED DURING THE REMOVAL. THE GUIDE WAS CAUGHT IN THE CATHETER AND THE GUIDE UNRAVELED. THE GUIDE WAS REMOVED WITH THE CATHETER. THIS INCIDENT HAPPENED WITH A SECOND UNIT. THE SECOND EVENT IS DOCUMENTED IN MDR# 3006425876-2017-00389.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE INSERTION WAS SUCCESSFUL, THE ISSUE HAPPENED DURING THE REMOVAL. THE GUIDE WAS CAUGHT IN THE CATHETER AND THE GUIDE UNRAVELED. THE GUIDE WAS REMOVED WITH THE CATHETER. THIS INCIDENT HAPPENED WITH A SECOND UNIT. THE SECOND EVENT IS DOCUMENTED IN MDR# 3006425876-2017-00389.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626538 ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM CATHETER, HEMODIALYSIS,NON-IMPLANT MPB ARROW INTERNATIONAL INC. 71F17D2472

    Patients

    Seq Age Sex Outcome Treatment
    1