BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER METRO DIRECT WIRE GUIDE

    MDR report key: 3829341 · Received February 28, 2014

    Report

    Report Number
    1037905-2014-00078
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KOG
    PMA / PMN Number
    K910497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE RETURNED WIRE HAD SOME MINOR BENDS NEAR THE DISTAL END. THE WIRE GUIDE WAS ADVANCED INTO A FS-OMNI SPHINCTEROTOME. THE SPHINCTEROTOME WAS ADVANCED THROUGH A DUODENOSCOPE THAT WAS PLACED IN A SIMULATED BILIARY POSITION WITHIN THE UPPER GI SIMULATOR (KOKEN MODEL LM-014). THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2 MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160VR). THE SPHINCTEROTOME WAS REMOVED AND WIRE GUIDE LEFT IN PLACE. THE FS-QEB-A EXTRACTION BALLOON RETURNED WITH THE WIRE GUIDE AND WAS ADVANCED OVER THE RETURNED WIRE GUIDE. WHEN THE EXTRACTION BALLOON WAS WITHDRAWN FROM THE WIRE GUIDE THERE WAS SOME FRICTION AND CATCHING DURING REMOVAL MAKING IT DIFFICULT TO MAINTAIN WIRE GUIDE POSITION. THE EXTRACTION BALLOON OUTER DIAMETER WAS CHECKED AND WAS WITH APPROPRIATE SPECIFICATIONS. THERE WAS SOME DAMAGE NOTED TO THE INTRA-DUCTAL EXCHANGE (IDE) PORT OF THE EXTRACTION BALLOON THAT COULD HAVE CONTRIBUTED TO THE DIFFICULTY WITHDRAWING THE EXTRACTION BALLOON. NO PART OF THE RETURNED DEVICES WAS MISSING. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. 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 A WIRE GUIDE STATE, "FOR BEST RESULTS, WIRE GUIDES SHOULD BE KEPT WET." INSTRUCTIONS FOR USE FOR THE FS-QEB-A EXTRACTION BALLOON STATE, "ADVANCE DISENGAGED WIRE GUIDE TO MAINTAIN DUCTAL ACCESS." UTILIZING THESE STEPS WILL FACILITATE THE WIRE GUIDE REMAINING IN POSITION DURING EXCHANGES. PRIOR TO DISTRIBUTION, ALL TRACER METRO DIRECT WIRE GUIDE ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED REMOTE. 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), A COOK TRACER METRO DIRECT WIRE GUIDE WAS USED. WHEN REMOVING THE EXTRACTION BALLOON FROM THE AMPULA, THE WIRE GUIDE KEPT FALLING OUT OF THE DUCT. THE PROCEDURE WAS ABLE TO BE COMPLETED USING THIS DEVICE. AFTER THE PROCEDURE THE WIRE GUIDE WAS NOTED TO BE BENT. THE TECHNICIAN COMMENTED THAT THERE WERE FOUR (4) STONES IN THE ENDOSCOPE CHANNEL THAT COULD HAVE BEEN PINCHING ON THE WIRE WHILE IN THE ELEVATOR. 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
    124547 TRACER METRO DIRECT WIRE GUIDE KOG, ENDOSCOPE AND/OR ACCESSORIES KOG WILSON-COOK MEDICAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 REQUEST COOK FS-OMNI-35-260 SPHINCTEROTOME| COOK FS-QEB-A EXTRACTION BALLOON| OLYMPUS GIF 180 ENDOSCOPE