BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER METRO DIRECT WIRE GUIDE

    MDR report key: 2231613 · Received August 15, 2011

    Report

    Report Number
    1037905-2011-00535
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    July 20, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KOG
    PMA / PMN Number
    K910497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD AND SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER INVOLVED COULD NOT BE DETERMINED. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INFO PROVIDED INDICATED THE ACCESSORY DEVICE USED WITH THIS WIRE GUIDE HAS A METAL TIP. THIS IS THE CAUSE FOR THE OCCURRENCE. THE INSTRUCTIONS FOR USE CAUTION THE USER THAT USE OF THIS WIRE GUIDE WITH METAL TIP ERCP DEVICES MAY RESULT INF DAMAGE TO THE EXTERNAL COATING AND/OR TIP OF THE WIRE GUIDE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO EXCHANGE COMPATIBLE WIRE-GUIDED ACCESSORIES OVER THE WIRE GUIDE. IF THESE INSTRUCTIONS ARE NOT FOLLOWED, THIS CAN CONTRIBUTE TO THIS OCCURRENCE. DURING MANUFACTURE, THE WIRE GUIDES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE THE WIRE GUIDE IS FREE OF SURFACE IMPERFECTIONS AND EXPOSED WIRE. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A HEPATICOGASTROSTOMY OR HEPATICODUODENOSTOMY, THE PHYSICIAN USED A COOK ECHOTIP ULTRA ULTRASOUND ACCESS NEEDLE (METAL-TIPPED DEVICE) AND A COOK TRACER METRO DIRECT WIRE GUIDE TO ACCESS THE BILE DUCT SUCCESSFULLY. THE NEEDLE WAS REMOVED AND A 7 FRENCH CYSTOTOME MADE BY ANOTHER MFR WAS ADVANCED OVER THE WIRE GUIDE. CAUTERY WAS APPLIED THROUGH THE CYSTOTOME FOR ENTRY TO THE BILE DUCT. WHEN THE CYSTOTOME WAS REMOVED, THE WIRE GUIDE REPORTEDLY CAME BACK WITH THE CYSTOTOME AND WAS FOUND TO BE BROKEN. ANOTHER DEVICE HAD TO BE USED BUT THE PROCEDURE WAS NOT COMPLETED. THE PHYSICIAN INDICATED AN INCOMPLETE PROCEDURE WAS LIKELY TO BE THE OUTCOME AND THE PT WAS TREATED SUCCESSFULLY. THE PT IS REPORTEDLY OK. A SECTION OF THE WIRE GUIDE DID NOT DETACH INSIDE THE PT; NOTHING HAD TO BE RETRIEVED. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO BREAKAGE OF THE WIRE GUIDE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO WIRE GUIDE BREAKAGE. THE PHYSICIAN ASSUMED THAT THE CYSTOTOME CAUSED THE BREAKAGE AND DID NOT INDICATE THE WIRE GUIDE FAILED IN ANY WAY. THE PHYSICIAN IS AWARE THAT THE NEEDLE WAS BEING USED OFF-LABEL AND PROVIDED THE INFO TO COOK IN THE HOPE THAT THE PHYSICIAN CAN IDENTIFY PROBLEMS WITH WHAT IS A DIFFICULT PROCEDURE AND DETERMINE IF THIS IS RELATED TO SOMETHING THE PHYSICIAN IS DOING OR SOMETHING THE DEVICES ARE NOT MADE TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACER METRO DIRECT WIRE GUIDE KOG, ENDOSCOPE AND/OR ACCESSORIES KOG WILSON-COOK MEDICAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 FR CYSTOTOME (NOT MADE BY COOK)| COOK ULTRASOUND NEEDLE ((B)(4))