BEUDAMED
    FDA Adverse Event Death Summary report: N

    CVC SET: 3-LUMEN 12 FR X 20 CM

    MDR report key: 2450001 · Received February 10, 2012

    Report

    Report Number
    1036844-2012-00041
    Event Type
    Death
    Date Received
    February 10, 2012
    Date of Event
    September 21, 2011
    Report Date
    February 10, 2012
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FOZ
    PMA / PMN Number
    K970864
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER CONTROL NO. (B)(4). DEVICE EVALUATION: THE SAMPLE WAS RECEIVED WITH THE GUIDE WIRE SEPARATED INTO TWO FRAGMENTS. ONE FRAGMENT INCLUDES THE CORE WIRE, THE DISTAL PORTION OF COIL WIRE AND THE DISTAL WELD. THE OTHER FRAGMENT WAS RETURNED INSIDE THE DISTAL LUMEN OF THE CATHETER. THE COILS ARE STRETCHED AND PROTRUDE FROM BOTH ENDS OF THE CATHETER. THE FRAGMENT INCLUDES THE PROXIMAL PORTION OF THE COIL WIRE AND THE PROXIMAL WELD. THE COIL WIRE IS COMPLETELY STRETCHED EXCEPT FOR APPROXIMATELY 4.5CM OF COILS THAT REMAIN TOGETHER NEAR THE PROXIMAL WELD. THE GUIDE WIRE WAS EXAMINED MICROSCOPICALLY. BOTH WELDS ARE FULL AND ROUND. THE DISTAL WELD REMAINS ATTACHED TO THE CORE AND COIL WIRES. THE PROXIMAL WELD REMAINS ATTACHED ONLY TO THE COIL WIRE. THE CORE WIRE IS BROKEN ADJACENT TO THE PROXIMAL WELD. DISCOLORATION AT THE BROKEN END OF THE CORE WIRE IS CONSISTENT WITH PROXIMITY TO A WELD. MICROSCOPIC INSPECTION REVEALED A PLASTIC DEFORMATION AND NECKING AT THE SEPARATED END OF THE CORE WIRE. THE CORE WIRE MEASURES APPROXIMATELY 68CM IN LENGTH WHICH INDICATES THAT NO PIECES OF THE CORE WIRE APPEAR TO BE MISSING. THE DIAMETER OF THE GUIDE WIRE WAS MEASURED AND IS WITHIN SPECIFICATION. INSTRUCTIONS FOR USE DESCRIBE SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. THE INSTRUCTIONS STATE THAT IF RESISTANCE IS ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE GUIDE WIRE AFTER CATHETER PLACEMENT, THE GUIDE WIRE MAY BE KINKED ABOUT THE TIP OF THE CATHETER WITHIN THE VESSEL. IN THIS CASE, IT IS RECOMMENDED TO WITHDRAW THE CATHETER RELATIVE TO THE GUIDE WIRE ABOUT 2-3 CM AND THEN ATTEMPT TO REMOVE THE GUIDE WIRE. THE INSTRUCTIONS CAUTION THAT WITHDRAWING THE GUIDE WIRE AGAINST THE NEEDLE BEVEL OR USE OF EXCESSIVE FORCE DURING REMOVAL COULD DAMAGE OR BREAK THE WIRE. THE DEVICE HISTORY RECORDS FOR THE GUIDE WIRE WERE REVIEWED WITH NO FINDINGS RELEVANT TO THIS COMPLAINT. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THE REPORTED COMPLAINT OF GUIDE WIRE SEPARATION WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE RETURNED SAMPLE. THE COIL WIRE IS STRETCHED AND BROKEN. THE CORE WIRE IS BROKE ADJACENT TO THE PROXIMAL WELD. NO MANUFACTURING DEFECTS WERE FOUND DURING THIS INVESTIGATION. ARROW GUIDE WIRES ARE DESIGNED AND MANUFACTURED TO WITHSTAND A TENSILE FORCE THAT EXCEEDS THE MINIMUM FORCE SPECIFIED BY THE ISO STANDARD 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. QUARTERLY TRENDING INDICATES A LOW, STABLE RATE FOR UNRAVELED OR SEPARATED GUIDE WIRE COMPLAINTS. BASED ON THESE CIRCUMSTANCES, THE POTENTIAL CAUSE OF THIS ISSUE IS PROCEDURE/PATIENT ANATOMY RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT INVOLVED IN THIS EVENT WAS A (B)(6) FEMALE. WHILE IN THE INTENSIVE CARE UNIT, THE CATHETER WAS INSERTED INTO THE PATIENT'S SUBCLAVIAN, THEN THE CLINICIAN ATTEMPTED TO REMOVE THE SWG. IT WAS AT THE TIME OF REMOVAL THAT THE SWG BROKE AND AS A RESULT, A NEW KIT WAS OPENED. THE OUTCOME OF THE PATIENT WAS DEATH, HOWEVER, THE DEATH OF THE PATIENT WAS NOT RELATED TO THE ISSUE AS THE HEALTH OF THE PATIENT WAS "SEVERE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 12 FR X 20 CM ADULT MULTI-LUMEN CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC RF1023137

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death