BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 8FR X 20CM

    MDR report key: 6058662 · Received October 26, 2016

    Report

    Report Number
    3006425876-2016-00340
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    September 17, 2016
    Report Date
    September 26, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE EVALUATION: THE REPORTED COMPLAINT OF THE GUIDE WIRE UNRAVELED WAS CONFIRMED. THE CUSTOMER RETURNED ONE GUIDE WIRE. THE CATHETER WAS NOT RETURNED. VISUAL EXAMINATION CONFIRMED THAT THE GUIDE WIRE IS UNRAVELED FROM THE DISTAL WELD AND THE DISTAL WELD IS ATTACHED TO THE END OF THE COIL WIRE. ONE KINK WAS OBSERVED IN THE GUIDE WIRE. MICROSCOPIC EXAMINATION CONFIRMED THAT BOTH WELDS ARE FULL AND SPHERICAL AND THAT THE CORE WIRE WAS FOUND BROKEN ADJACENT TO THE DISTAL WELD. A DISCOLORATION AND NECKING OF THE CORE WIRE WAS ALSO OBSERVED IN THE AREA OF THE BREAK. DISCOLORATION AT THE BROKEN END OF THE CORE WIRE IS CONSISTENT WITH PROXIMITY TO A WELD. A MANUAL TUG TEST CONFIRMED THAT THE PROXIMAL WELD REMAINS INTACT. KINK WAS OBSERVED AT 29.8 CM FROM THE DISTAL END OF THE CORE WIRE. THE BROKEN CORE WIRE MEASURED 602 MM IN LENGTH, WHICH MEETS THE LENGTH SPECIFICATION OF 596- 604 MM PER THE GUIDE WIRE GRAPHIC; THEREFORE, NO PIECES APPEAR TO BE MISSING. THE DIAMETER OF THE GUIDE WIRE MEASURED 0.799 MM, WHICH ALSO IS WITHIN THE OUTSIDE DIAMETER SPECIFICATION OF 0.788MM - 0.826 MM PER THE GUIDE WIRE GRAPHIC. THE INSTRUCTIONS FOR USE DESCRIBES SUGGESTED OTHER REMARKS: 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 DEVICE HISTORY RECORDS WERE REVIEWED WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED ISSUE. 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 CAUSED OR CONTRIBUTED TO THE EVENT. NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION IN NEUROSURGERY, WHEN REMOVING THE GUIDE WIRE FROM THE FEMALE PATIENT'S RIGHT SUBCLAVIAN VEIN, THE GUIDE WIRE STRETCHED. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708388 CVC SET: 2-LUMEN 8FR X 20CM ADULT MULTI LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC. 71F16B1598

    Patients

    Seq Age Sex Outcome Treatment
    1