BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER HYBRID WIRE GUIDE

    MDR report key: 3952522 · Received May 15, 2014

    Report

    Report Number
    1037905-2014-00190
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 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

    A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LAB SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LAB 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 MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUAL ENGINEERING RISK ASSESSMENT. QUAL 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 BILE DUCT USING THE COOK FUSION OMNI-TOME SPHINCTEROTOME (FS-OMNI). A COOK FUSION QUATTRO EXTRACTION BALLOON (FS-QEB-A) WAS ADVANCED OVER THE WIRE GUIDE AND AS THE TIP OF THE EXTRACTION BALLOON 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 PT. ANOTHER COOK WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORT. THE WIRE GUIDE WAS RETURNED WITH A FS-QEB-A BALLOON. THE WIRE GUIDE WAS STILL INSIDE THE BALLOON WITH THE DISTAL END OF THE WIRE GUIDE COMING OUT OF THE DISTAL END OF THE BALLOON CATHETER AND THE PROXIMAL SIDE OF THE WIRE GUIDE EXITING THE BALLOON WITH THE DISTAL END OF THE WIRE GUIDE COMING OUT OF THE DISTAL END OF THE BALLOON CATHETER AND THE PROXIMAL SIDE OF THE WIRE GUIDE EXITING THE IDE PORT OF THE BALLOON. APPROXIMATELY 12 CM FROM THE DISTAL END OF THE WIRE GUIDE IS A 10 CM SECTION OF EXPOSED CORE WIRE OF THE WIRE GUIDE. THE COATING OF THE WIRE GUIDE HAD ROLLED OVER ITSELF AND BUNCHED UP ON BOTH ENDS OF THE EXPOSED CORE WIRE PREVENTING IT FROM BEING EXTRACTED FROM THE BALLOON. THE WIRE GUIDE WAS CUT FROM THE DISTAL END OF THE BALLOON AND EXTRACTED FROM THE BALLOON. THE IDE PORT OF THE BALLOON WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. TO CHECK WHETHER THE IDE PORT OF THE BALLOON CONTRIBUTED TO THE REPORT A NEW WIRE GUIDE WAS ADVANCED INTO A OLYMPUS GIF Q20 2.8 ENDOSCOPE IN A SIMULATED UPPER GI POSITION WITH THE TIP IN A RETROFLEXED POSITION TO SIMULATE A WORST CASE SITUATION. THE RETURNED BALLOON WAS ADVANCED OVER THE NEW WIRE GUIDE. NO DAMAGE WAS OBSERVED ON THE NEW WIRE GUIDE FROM TESTING WITH THE RETURNED BALLOON. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291059 TRACER HYBRID WIRE GUIDE ENDOSCOPE AND/OR ACCESSORIES KOG WILSON-COOK MEDICAL INC. W3398785

    Patients

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