BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER HYBRID WIRE GUIDE

    MDR report key: 3851955 · Received April 15, 2014

    Report

    Report Number
    1037905-2014-00133
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 19, 2014
    Report Date
    March 19, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KOG
    PMA / PMN Number
    K910497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE COATING DAMAGE IS LOCATED NEAR THE DISTAL TIP IN THE BLUE AREA OF THE WIRE GUIDE COATING. APPROXIMATELY 11CM FROM THE DISTAL END IS A 2.5CM SECTION OF EXPOSED CORE WIRE. THE COATING HAS BEEN PULLED OVER ITSELF TOWARDS THE DISTAL END. A FUSION OASIS ONE ACTION STENT INTRODUCTION SYSTEM (FS-OA-10) WAS RETURNED WITH THE DAMAGED WIRE GUIDE. THERE WAS A MINOR KINK IN THE FUSION OASIS ONE ACTION STENT INTRODUCTION SYSTEM (FS-OA-10) APPROXIMATELY 11 CM FROM THE DISTAL END. NO PART OF EITHER DEVICE IS MISSING. THE FUSION OASIS ONE ACTION STENT INTRODUCTION SYSTEM (FS-OA-10) RETURNED WITH THE COMPLAINT WIRE GUIDE WAS THEN TESTED WITH AN UNUSED TRACER HYBRID WIRE GUIDE (HYB-48025). THE WIRE GUIDE WAS ADVANCED INTO AN OLYMPUS JF-130 3.2MM ENDOSCOPE WITH THE TIP IN A RETROFLEXED POSITION TO SIMULATE A WORST CASE SITUATION. THE FUSION OASIS ONE ACTION STENT INTRODUCTION SYSTEM (FS-OA-10) THAT WAS RETURNED WITH THE COMPLAINT WIRE GUIDE WAS ADVANCED OVER THE NEW TRACER HYBRID WIRE GUIDE (HYB-48025). NO DIFFICULTY WAS ENCOUNTERED AND NO DAMAGE OCCURRED TO THE NEW WIRE GUIDE. THE DEVICES FUNCTIONED AS INTENDED. 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 CONCLUSIONS: 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 FOR USE FOR THIS PRODUCT LINE INSTRUCT THE USER TO FLUSH THE WIRE GUIDE PRIOR TO REMOVAL FROM THE WIRE GUIDE HOLDER. THIS ACTIVITY WILL AID IN OPTIMAL PERFORMANCE OF THE WIRE GUIDE. FAILURE TO FLUSH THE WIRE GUIDE CAN RESULT IN DAMAGE TO THE WIRE GUIDE. THE INSTRUCTIONS FOR USE FOR THIS PRODUCT LINE INSTRUCT THE USER TO FLUSH ENDOSCOPE ACCESSORY CHANNEL AND/OR LUMEN OF DEVICE WITH STERILE WATER AND FOR BEST RESULTS, WIRE GUIDE SHOULD BE KEPT WET. THIS ACTIVITY WILL AID IN OPTIMAL PERFORMANCE OF WIRE GUIDE. FAILURE TO FLUSH THE ENDOSCOPE CHANNEL CAN RESULT IN DAMAGE TO THE WIRE GUIDE. 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 EXTERNAL COATING ON 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 COATING DAMAGE. PRIOR TO DISTRIBUTION, ALL TRACER HYBRID WIRE GUIDES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: 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 HYBRID WIRE GUIDE. THE WIRE GUIDE WAS PLACED IN THE PANCREATIC DUCT USING THE COOK FUSION OMNI-TOME SPHINCTEROTOME (FS-OMNI). A COOK FUSION OASIS ONE ACTION STENT INTRODUCTION SYSTEM (FS-OA-10) WAS ADVANCED OVER THE WIRE GUIDE AND AS THE TIP OF THE GUIDING CATHETER EXITED THE DISTAL END OF THE ENDOSCOPE, IT STRIPPED THE COATING OF THE WIRE GUIDE. NO SECTION OF THE DEVICE DETACHED AND BECAME FREE INSIDE THE PATIENT. ANOTHER COOK WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE. 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
    230240 TRACER HYBRID WIRE GUIDE KOG, ENDOSCOPE AND/OR ACCESSORIES KOG WILSON-COOK MEDICAL INC. W3396726

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK FUSION OMNI-TOME SPHINCTEROTOME| (FS-OA-10)| OLYMPUS TJF-160VF ENDOSCOPE,| COOK FUSION OASIS ONE ACTION STENT INTRO SYSTEM