BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    MDR report key: 2861470 · Received November 28, 2012

    Report

    Report Number
    1037905-2012-00656
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 29, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    KNS
    PMA / PMN Number
    K052051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS THE BREAKTHROUGH CHANNEL HAS BEEN UTILIZED FULLY THUS PROHIBITING A FUNCTIONAL EVALUATION TO BE UNDERTAKEN. DURING THE VISUAL INSPECTION IT WAS NOTED THAT THE OUTER EDGES OF THE CHANNEL WERE RIPPLED AND TORN, INDICATING DIFFICULTY WITH ZIP EXCHANGE. NO KINKS, BENDS OR TUBE TWISTING WERE PRESENT ON THE CATHETER. SIX UNUSED DEVICES WERE RETURNED IN ADDITION TO THE PRODUCT SAID TO BE INVOLVED. UNUSED DEVICE NUMBER 1: OUR LABORATORY EVALUATION OF THE RETURNED PRODUCT WAS UNABLE TO CONFIRM THE REPORT. DURING THE VISUAL EVALUATION IT WAS NOTED THAT NO KINKS, BENDS OR TUBE TWISTING WERE EVIDENT ON THE CATHETER, A FUNCTIONAL TEST WAS CONDUCTED TO TEST THE ZIP CHANNEL. DURING OUR LABORATORY ANALYSIS, THE SPHINCTEROTOME WAS PREPPED AND WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE BREAKTHROUGH CHANNEL WAS UTILIZED THE FULL LENGTH OF THE CHANNEL AND LOSS OF WIREGUIDE ACCESS DID NOT OCCUR. RESISTANCE WAS NOT ENCOUNTERED. AFTER THE EXCHANGE, THE OUTER EDGES OF THE CHANNEL AT APPROXIMATELY 32CM FROM THE DISTAL END WERE NOTED TO BE RIPPLED AND TORN INDICATING POTENTIAL DIFFICULTY WITH ZIP EXCHANGE ALTHOUGH THE EXCHANGE WAS SUCCESSFUL. THE PRODUCT FUNCTIONED AS INTENDED. UNUSED DEVICE NUMBER 2: OUR LABORATORY EVALUATION OF THE RETURNED PRODUCT WAS UNABLE TO CONFIRM THE REPORT. DURING THE VISUAL EVALUATION IT WAS NOTED THAT NO KINKS OR BENDS WERE EVIDENT ON THE CATHETER. IT WAS NOTED THAT THE TUBING PRESENTED AT 180 DEGREES TWIST APPROXIMATELY 15CM FROM THE PROXIMAL WIRE GUIDE PORT OF THE CATHETER. A FUNCTIONAL TEST WAS CONDUCTED TO TEST THE ZIP CHANNEL. DURING OUR LABORATORY ANALYSIS, THE SPHINCTEROTOME WAS PREPPED AND WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER TJF-160V). THE BREAKTHROUGH CHANNEL WAS UTILIZED THE FULL LENGTH OF THE CHANNEL AND LOSS OF WIREGUIDE ACCESS DID NOT OCCUR. RESISTANCE WAS NOT ENCOUNTERED. AFTER THE EXCHANGE, THE OUTER EDGES OF THE CHANNEL AT APPROXIMATELY 39CM FROM THE DISTAL END WERE NOTED TO BE RIPPLED AND TORN, INDICATING POTENTIAL DIFFICULTY WITH ZIP EXCHANGE ALTHOUGH THE EXCHANGE WAS SUCCESSFUL. THE TUBE TWISTING AND THE RIPPLED EDGES DID NOT OCCUR AT THE SAME LOCATION ON THE CATHETER. THE PRODUCT FUNCTIONED AS INTENDED. UNUSED DEVICES 3, 4, AND 6: OUR LABORATORY EVALUATION OF THE RETURNED PRODUCTS WERE UNABLE TO CONFIRM THE REPORT. DURING THE VISUAL EVALUATION IT WAS NOTED THAT NO KINKS, BENDS OR TUBE TWISTING WERE EVIDENT ON THE CATHETER OF THE DEVICES. A FUNCTIONAL TEST WAS CONDUCTED TO TEST THE ZIP CHANNEL. DURING OUR LABORATORY ANALYSIS, THE SPHINCTEROTOMES WERE PREPPED AND ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL # OLYMPUS TJF-160V). FOR EACH DEVICE THE BREAKTHROUGH CHANNEL WAS UTILIZED THE FULL LENGTH OF THE CHANNEL AND LOSS OF WIREGUIDE ACCESS DID NOT OCCUR. RESISTANCE WAS NOT ENCOUNTERED. AFTER THE EXCHANGE, THE OUTER EDGES OF THE CHANNEL WERE SMOOTH. THE DEVICES FUNCTIONED AS INTENDED. UNUSED DEVICE NUMBER 5: OUR LABORATORY EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORT. DURING THE VISUAL EVALUATION IT WAS NOTED THAT NO KINKS OR BENDS WERE EVIDENT OF THE CATHETER. IT WAS NOTED THAT THE TUBING PRESENTED AT 180 DEGREES TWIST APPROXIMATELY 20CM FROM THE PROXIMAL WIRE GUIDE PORT OF THE CATHETER. A FUNCTIONAL TEST WAS CONDUCTED TO TEST THE ZIP CHANNEL. DURING OUR LABORATORY ANALYSIS, THE SPHINCTEROTOME WAS PREPPED AND WAS ADVANCED THROUGH A DUODENOSCOPE THAT IS PLACED IN A SIMULATED BILIARY POSITION. THE DUODENOSCOPE HAS AN ACCESSORY CHANNEL THAT IS 4.2MM IN DIAMETER (MODEL NUMBER OLYMPUS TJF-160V). THE BREAKTHROUGH CHANNEL WAS UTILIZED APPROXIMATELY 33CM OF THE CHANNEL AND LOSS OF WIREGUIDE ACCESS DID OCCUR. SEVERE RESISTANCE WAS ENCOUNTERED AND THE REMAINDER OF THE EXCHANGE COULD NOT BE ACHIEVED. THE OUTER EDGES OF THE CHANNEL THAT WERE ZIPPED WERE NOTED TO BE RIPPLED AND TORN. DUE TO THE SEVERE RESISTANCE ENCOUNTERED FURTHER EVALUATION OF THE CATHETER TUBING WAS CONDUCTED. A SECTION OF THE CATHETER WAS DISSECTED BELOW THE ZIPPED PORTION AND EXAMINED USING A RAM QC5600. THE WIREGUIDE LUMEN DIAMETER WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. THE PRESENCE OF A TEARDROP ON THE WIREGUIDE LUMEN WAS CLEARLY IDENTIFIABLE AND THE DISTANCE FROM THE TEARDROP OF THE LUMEN TO THE OUTER DIAMETER OF THE CATHETER WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED IN REGARD TO THE DIMENSIONAL ANALYSIS OF THE CATHETER. 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. RESISTANCE IN WIRE GUIDE AND WIRE GUIDE LUMEN SEPARATION CAN OCCUR IF THE CATHETER OF THE SPHINCTEROTOME BECOMES DAMAGED (I.E. KINK OR BEND). A KINK IN THE SPHINCTEROTOME CAN OCCUR IF THE DEVICE RECEIVED ADDED PRESSURE DURING ADVANCEMENT THROUGH THE ENDOSCOPE OR GENERAL HANDLING. THE INSTRUCTIONS FOR USE CAUTION THE USER THE ELEVATOR SHOULD REMAIN OPEN/DOWN WHEN ADVANCING OR RETRACTING THE SPHINCTEROTOME. IF THE ELEVATOR OF THE ENDOSCOPE IS PLACED IN THE CLOSED/UP POSITION WITH THE SPHINCTEROTOME INSIDE THE ACCESSORY CHANNEL, THIS COULD CAUSE A KINK IN THE SPHINCTEROTOME AND LEAD TO WIRE GUIDE AND WIRE GUIDE LUMEN SEPARATION DIFFICULTY. INSTRUCTIONS FOR USE STATES FOR BEST RESULTS WIRE GUIDE SHOULD BE KEPT WET. PRIOR TO DISTRIBUTION, ALL FUSION OMNI-TOME SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST 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) IN THE LIVER, A COOK FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME WAS USED. THE BREAKTHROUGH CHANNEL OF THE SPHINCTEROTOME DID NOT WORK PROPERLY. THE SPLITTING WORKED POORLY. THE RESULT WAS THAT THE GUIDEWIRE WAS TRAPPED/CAUGHT IN THE BREAKTHROUGH CHANNEL AND DID NOT STAY IN THE LOCKED POSITION IN THE WIRELOCK. THEY OBSERVED THAT THE BREAKTHROUGH CHANNEL SPLITTING WAS NOT SMOOTH. ALL THE WAY DOWN IT WAS TORN AND NOT AS SMOOTH AS IT SHOULD BE. WE REQUESTED CLARIFICATION REGARDING THIS OCCURRENCE. SPECIFICALLY, WE ASKED IF WIRE GUIDE ACCESS WAS LOST. THE ANSWER PROVIDED INDICATED THE PHYSICIAN TOOK A SPHINCTEROTOME MADE BY ANOTHER COMPANY AND CANNULATED AGAIN. THEREFORE, WIRE GUIDE ACCESS WAS LOST AND HAD TO BE ESTABLISHED AGAIN. THE PROCEDURE WAS FINISHED WITH THIS SPHINCTEROTOME. 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
    1 FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME KNS, ENDOSCOPIC ELECTROSURGICAL UNIT AND ACCESSORIES KNS WILSON-COOK MEDICAL INC. W3185411

    Patients

    Seq Age Sex Outcome Treatment
    1 FS-WL-O-S WIRELOCK| OLYMPUS V-SCOPE: MODEL #UNK| FSW-35 WIREGUIDE