BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER HYBRID WIRE GUIDE

    MDR report key: 4041105 · Received August 14, 2014

    Report

    Report Number
    1037905-2014-00321
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 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 EVAL: OUR EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORT. APPROXIMATELY 14.5 CM FROM THE DISTAL END IS A 2.5 CM SECTION OF EXPOSED CORE WIRE. THE COATING HAS ROLLED OVER ITSELF TOWARDS THE DISTAL END. ACCORDING TO THE REPORT NO PART OF THE COVERING HAS SEPARATED. DUE TO THE CONDITION OF THE RETURNED DEVICE IT COULD NOT BE DETERMINED IF PART OF THE DEVICE WAS MISSING. THE SKIVE OF THE FS-QEB-A BALLOON RETURNED WITH THE WIRE GUIDE WAS EXAMINED. THERE WAS MINOR DAMAGE TO THE DISTAL END OF THE SKIVE. A NEW HYB-48015 WIRE GUIDE WAS ADVANCED INTO AN OLYMPUS JF130 3.2 ENDOSCOPE IN A SIMULATED UPPER GL POSITION WITH THE TIP IN A RETROFLEXED POSITION TO SIMULATE A WORST CASE SITUATION. THE TIP OF THE BALLOON WAS ADVANCED ONTO THE PREPOSITIONED NEW WIRE GUIDE WITH THE WIRE GUIDE EXITING THE BALLOON CATHETER AT THE IDE PORT. THE FS-QEB-A RETURNED WITH THE COMPLAINT DEVICE WAS ADVANCED OVER THE NEW WIRE GUIDE UNTIL IT EXITED THE DISTAL END OF THE SCOPE. THE BALLOON WAS THEN RETRACTED. THE NEW WIRE GUIDE WAS EXAMINED AND THERE WAS NO DAMAGE TO THE WIRE GUIDE. THE IDE PORT OF THE FS-QEB-A RETURNED WITH THE COMPLAINT DEVICE WAS MEASURED AND FOUND TO BE WITHIN THE SPECIFICATION. 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 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 THE 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. AS THE COOK FUSION EXTRACTION BALLOON (FS-QEB-A) WAS ADVANCED OVER THE DISTAL END OF THE WIRE GUIDE, THE COATING OF THE WIRE STRIPPED OFF WHERE THE WIRE WAS EXITING THE CATHETER, 9 EM FROM THE DISTAL TIP OF THE CATHETER. THE COATING STAYED ON THE DEVICE. NO SECTION OF THE DEVICE DETACHED AND BECAME FREE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WIRE GUIDE. 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
    487490 TRACER HYBRID WIRE GUIDE KOG, ENDOSCOPE AND/OR ACCESSORIES KOG WILSON-COOK MEDICAL INC. W3431019

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK FUSION OMNI-TOME SPHINCTEROTOME (FS-OMNI)| OLYMPUS TJF-160VF ENDOSCOPE| COOK FUSION EXCTRACTION BALLOON (FS-QEB-A)