BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER METRO DIRECT WIRE GUIDE

    MDR report key: 4093200 · Received August 21, 2014

    Report

    Report Number
    1037905-2014-00326
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KOG
    PMA / PMN Number
    K910497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORT. THE DISTAL 9 CM OF THE WIRE GUIDE HAD A BEND. THE DISTAL 1.5 CM HAD COATING THAT WAS FRAYED FROM THE BARE COIL SPRING. THE COIL SPRING WAS INTACT AND MANUFACTURED AT THE DISTAL TIP AS INTENDED. THE 1.5 CM OF COATING AT THE DISTAL END EXHIBITED A SPLIT BUT WAS STILL ATTACHED. DUE TO THE CONDITION OF THE DISTAL END OF THE WIRE GUIDE IT CANNOT BE DETERMINED IF A SMALL SECTION OF THE COATING IS MISSING. ACCORDING TO THE REPORT NO SECTION OF THE DEVICE DETACHED INSIDE THE PATIENT OR ENDOSCOPE. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. THE INSTRUCTIONS ADVISE THE USER THAT THE WIRE GUIDE SHOULD BE KEPT WET FOR BEST RESULTS. THE INSTRUCTIONS FOR USE DESCRIBE THE APPROPRIATE FLUSHING TECHNIQUES FOR USE OF THIS COATED WIRE GUIDE. THESE TECHNIQUES DESCRIBED INCLUDE FLUSHING THE WIRE GUIDE HOLDER WITH 30CC OF STERILE WATER PRIOR TO REMOVING THE WIRE GUIDE FROM THE HOLDER, FLUSHING THE ENDOSCOPE ACCESSORY CHANNEL AND/OR LUMEN OF ACCESSORY DEVICE WITH STERILE WATER BEFORE WIRE GUIDE INSERTION. IF THESE FLUSHING TECHNIQUES ARE NOT FOLLOWED OR INADEQUATE FLUSHING OCCURS, THIS CAN CONTRIBUTE TO WIRE GUIDE TIP DAMAGE. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT CAUTIONS THE USER THAT THIS PRODUCT IS COMPATIBLE WITH NON-METAL TIP DEVICES. USE OF THE WIRE GUIDE WITH METAL TIP DEVICES MAY COMPROMISE THE INTEGRITY OF THE WIRE GUIDE. THE REPORTED OBSERVATION CAN OCCUR IF THE WIRE GUIDE WAS USED WITH AN INCOMPATIBLE ACCESSORY DEVICE. IF ADDITIONAL PRESSURE IS APPLIED TO THE WIRE GUIDE AND/OR ACCESSORY DEVICE(S) WHILE MOVING THE WIRE GUIDE INSIDE THE ACCESSORY DEVICE(S), THIS COULD CONTRIBUTE TO WIRE GUIDE TIP DAMAGE. PRIOR TO DISTRIBUTION, ALL TRACER METRO WIRE GUIDE ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN UNUSUAL OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRACER METRO DIRECT WIRE GUIDE. THE DISTAL END OF THE WIRE GUIDE DAMAGED DURING THE PROCEDURE. NO SECTION OF THE DEVICE DETACHED INSIDE THE PATIENT OR ENDOSCOPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506548 TRACER METRO DIRECT WIRE GUIDE KOG, ENDOSCOPE AND/OR ACCESSORIES KOG WILSON-COOK MEDICAL INC. W3439128

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE: MODEL #UNK