BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 20 CM

    MDR report key: 6052224 · Received October 24, 2016

    Report

    Report Number
    1036844-2016-00539
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 14, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORT THAT THE GUIDE WIRE SEPARATED WAS CONFIRMED. RETURNED WAS A GUIDE WIRE. THE GUIDE WIRE WAS BENT AND KINKED ALONG ITS LENGTH AND WAS UNRAVELED AT THE DISTAL END. THE CORE WIRE WAS SEPARATED ADJACENT TO THE WELD AT THE DISTAL END. DISCOLORATION WAS OBSERVED AT THE BROKEN END OF THE CORE WIRE, WHICH IS CONSISTENT WITH PROXIMITY TO A WELD. MICROSCOPIC INSPECTION REVEALED A PLASTIC DEFORMATION AND NECKING OF THE WIRE IN THE AREA OF THE BREAK. THE DISTAL WELD WAS NOT ATTACHED TO THE COIL WIRE AND WAS NOT RETURNED. A MANUAL TUG TEST CONFIRMED THAT THE PROXIMAL WELD IS INTACT. THE CORE WIRE MEASURED APPROXIMATELY 60 CM IN LENGTH. BASED UPON THE MEASURED LENGTH OF THE BROKEN CORE WIRE, NO PIECES OF THE CORE WIRE APPEAR TO BE MISSING. THE OUTSIDE DIAMETER (OD) OF THE GUIDE WIRE MEASURED 0.788 MM. THIS MET SPECIFICATION OF 0.788 - 0.826 MM PER THE GUIDE WIRE GRAPHIC. THE INSTRUCTION BOOKLET PROVIDED WITH THE KIT DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. 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 SELECTED INSERTION SITE AND PATIENT ANATOMY MAY OTHER REMARKS: 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. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO RELEVANT FINDINGS. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. A RISK EVALUATION WAS COMPLETED FOR THIS COMPLAINT ISSUE. BASED ON THESE CIRCUMSTANCES, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. NO FURTHER ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN INSERTED THE CATHETER INTO THE PATIENT'S RIGHT INTERNAL JUGULAR. ON POST INSERTION X-RAY IT WAS NOTED THAT A PIECE OF THE GUIDE WIRE SEPARATED AND REMAINED IN THE PATIENT. THE PIECE WAS SUCCESSFULLY FOUND AND REMOVED. THERE WAS NO PATIENT DEATH REPORTED AND THE PATIENT OUTCOME WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701817 CVC KIT: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention