BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIWIRE NITINOL HYDROPHILIC WIRE GUIDE

    MDR report key: 1935988 · Received December 8, 2010

    Report

    Report Number
    1825146-2010-00054
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 11, 2010
    Report Date
    December 8, 2010
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    OCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WIRE GUIDE WAS REC'D ALONG WITH A SEGMENT OF THE OUTER JACKET. IN VIEWING THE WIRE GUIDE AN EXPOSED WIRE WAS PROTRUDING FROM THE OUTER JACKET 9 CM, NOTING THE APPEARANCE OF THE END OF SEPARATION TO HAVE BEEN CUT AT AN ANGLE. UNDER MICROSCOPIC VIEW THE JACKET WAS NOTED TO HAVE SEVERAL SCRAPES AND GOUGES STARTING AT THE AREA SEPARATION AND EXTENDING 12 CM DOWN THE BODY. THE SEGMENT RETURNED MEASURED 9 CM IN LENGTH, IN LOOKING AT THE SURFACE OF THE SEGMENT, SCRAPE MARKS WERE FOUND PRIMARILY THE LENGTH OF THE SEGMENT WITH THE END OF SEPARATION HAVING BEEN CUT AT AN ANGLE. IN MATING THE TWO PIECES TOGETHER THEY APPEAR TO BE MATCHING SURFACES. THE CUSTOMER HAD INDICATED THE WIRE WAS BEING WITHDRAWN FROM A NEEDLE WITH A PIECE OF THE WIRE COATING SHEARED OFF. WITHIN THE INSTRUCTIONS FOR USE THAT IS SUPPLIED WITH THE DEVICE A PRECAUTION IS STATED AS FOLLOWS: WHEN USING WIRE GUIDE THROUGH A METAL CANNULA/NEEDLE, USE CAUTION AS DAMAGE MAY OCCUR TO THE OUTER COATING. MOST LIKELY UPON WITHDRAWING THE WIRE FROM THE NEEDLE, THE WIRE GUIDE HAS CAUGHT ON THE TIP CAUSING THE OUTER JACKET TO BE CUT AND LEFT INSIDE THE PT. A SECOND PROCEDURE WAS PERFORMED TO REMOVE ADDITIONAL STONES FROM THE KIDNEY ALONG WITH THE PORTION OF THE OUTER JACKET.

    Description of Event or Problem · 1

    THREE BOSTON SCIENTIFIC SENSOR WIRES AND TWO COOK BIWIRES WERE USED DURING THE CASE. WHEN THE UROLOGIST WAS GAINING ACCESS OR REMOVING THE WIRES, A PIECE OF THE WIRE COATING WAS SHEARED OFF BY THE TROCAR NEEDLE AND APPEARED TO BE LEFT IN THE PT. THE UROLOGIST DID NOT KNOW IF THE SHEARED OFF PIECE WAS IN THE KIDNEY OR OUTSIDE THE KIDNEY. AN ORTHOPEDIC SURGEON WAS CALLED IN FOR A SECOND PROCEDURE TO HELP RETRIEVE THE SHEARED OFF PIECE, BUT COULD NOT GET IT. THE PT WILL BE RESCHEDULED FOR MORE STONE REMOVAL AND TO RETRIEVE THE SHEARED OFF WIRE COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIWIRE NITINOL HYDROPHILIC WIRE GUIDE OCY COOK UROLOGICAL WIRE GUIDES OCY COOK UROLOGICAL, INC. NA 01420280

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR