BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIWIRE NITINOL HYDROPHILLIC WIRE GUIDE

    MDR report key: 2832978 · Received October 25, 2012

    Report

    Report Number
    1825146-2012-00025
    Event Type
    Injury
    Date Received
    October 25, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    OCY
    PMA / PMN Number
    K082536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SCRAPE MARKS WERE VISIBLE ON THE WIRE GUIDE COATING AND COATING WAS MISSING FOR 14 CM, STARTING AT 31.5 CM FROM THE DISTAL TIP OF THE WIRE GUIDE. COOK RECEIVED AN OPEN PACKAGE FROM THE HOSPITAL THAT CONTAINED A USED HIWIRE WIRE GUIDE. UPON VISUAL INSPECTION OF THE RETURNED PRODUCT, THE COATING OF THE WIRE GUIDE WAS DAMAGED AT 17.8 CM FROM THE DISTAL END, WITH VISIBLE SCRAPE MARKS ON THE WIRE GUIDE COATING. ADDITIONALLY, 14 CM OF THE WIRE GUIDE COATING, BEGINNING 31.5 CM FROM THE DISTAL TIP, WAS MISSING. IT APPEARS THAT THE DAMAGE TO THE WIRE GUIDE COATING AND THE PORTION THAT WAS SHEARED OFF OCCURRED WHEN THE USER ATTEMPTED TO REMOVE THE WIRE GUIDE BACK THROUGH THE TROCAR NEEDLE. PER THE INITIAL REPORT FROM THE USER FACILITY, THE WIRE GUIDE WAS BEING REMOVED THROUGH A TROCAR NEEDLE WHEN THE COATING WAS SHEARED OFF. THE INSTRUCTIONS FOR USE FOR THE HIWIRE WIRE GUIDE CONTAIN THE FOLLOWING PRECAUTION, "WHEN USING WIRE GUIDE THROUGH A METAL CANNULA/NEEDLE, USE CAUTION AS DAMAGE MAY OCCUR TO OUTER COATING." THE CAUSE OF THIS FAILURE MODE WAS USER ERROR.

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO REMOVE WIRE, PART OF COATING WAS SHEARED OFF THE WIRE. CONFIRMED BY THE PHYSICIAN ON (B)(6) 2012 (VIA EMAIL): THE WIRE WAS INTRODUCED THROUGH A COOK 18 GAUGE 2 PART TROCAR NEEDLE. IT WAS NOTICED THE WIRE COATING WAS SHEARED, BUT DID NOT NOTICE ANY PIECE LEFT BEHIND FLUOROSCOPICALLY. THE PHYSICIAN ALSO DID NOT ENCOUNTER ANY WIRE COATING WITHIN THE KIDNEY DURING THE OPERATION. A POST-OP CXR WAS OBTAINED, AND THE WIRE COATING WAS NOTICED NEAR THE DIAPHRAGM AT THAT TIME. INITIAL SURGERY: (PERCUTANEOUS NEPHROSTOLITHOTOMY) (B)(6) 2012. DATE OF FB EXTRACTION: (BY THORACIC SURGERY VIA VIDEO ASSISTED THORASCOPIC APPROACH) (B)(6) 2012. CONFIRMED BY PHYSICIAN ON (B)(6) 2012 - THE PT HAS BEEN CLINICALLY STABLE THROUGHOUT THE ENTIRE POSTOPERATIVE COURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIWIRE NITINOL HYDROPHILLIC WIRE GUIDE OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY - UROLOGY OCY COOK UROLOGICAL, INC. NA 10091555

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention