BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER HYBRID WIRE GUIDE

    MDR report key: 4737936 · Received March 17, 2015

    Report

    Report Number
    1037905-2015-00100
    Event Type
    Malfunction
    Date Received
    March 17, 2015
    Date of Event
    February 13, 2015
    Report Date
    February 16, 2015
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KOG
    PMA / PMN Number
    K910497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE WIRE GUIDE WAS RETURNED STILL INSIDE THE FS-QEB-A BALLOON. THE WIRE GUIDE WENT IN THE IDE PORT AND OUT THE DISTAL END. APPROXIMATELY 15 CM FROM THE DISTAL END IS A 2 CM SECTION OF BARE CORE WIRE. DUE TO THE CONDITION OF THE COATING IT CANNOT BE DETERMINED IF A SECTION IS MISSING. THE IDE PORT OF THE FS-QEB-A BALLOON WAS MEASURED AND IS WITHIN THE SPECIFICATION. THE BALLOON WAS ADVANCED OVER A NEW WIRE GUIDE WITH THE WIRE GUIDE EXITING THE IDE PORT. THE WIRE GUIDE HAD BEEN ADVANCED INTO AN OLYMPUS JF 130 3.2 SIDE VIEWING ENDOSCOPE IN A SIMULATED UPPER GL POSITION WITH THE TIP IN A RETROFLEXED POSITION TO SIMULATE A WORST CASE SITUATION. WHEN THE BALLOON WAS RETRACTED FROM THE ENDOSCOPE OVER THE NEW WIRE GUIDE NO DAMAGE WAS OBSERVED TO THE WIRE GUIDE. 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 JOT 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 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. 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) PROCEDURE, THE PHYSICIAN USED A COOK TRACER HYBRID WIRE GUIDE. THE WIRE GUIDE WAS ADVANCED INTO THE COMMON BILE DUCT. THE PHYSICIAN TRIED TO PULL BACK ON THE WIRE GUIDE AND IT WOULD NOT COME OUT OF THE BALLOON. THE WIRE GUIDE WAS DELAMINATED. APPROXIMATELY 7 CM BACK FROM THE TIP IS WHERE THE COATING BECAME DETACHED [DELAMINATED] THEN PULLED UP ONTO THE EXTRACTION BALLOON. THIS OCCURRED TOWARD THE END OF THE PROCEDURE BUT THE DEVICE WAS REMOVED AND THE PHYSICIAN USED ANOTHER BALLOON AND WIRE GUIDE TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES OR INTERVENTION REQUIRED DUE TO THIS OCCURRENCE. 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
    181197 TRACER HYBRID WIRE GUIDE KOG, ENDOSCOPE AND/OR ACCESSORIES KOG WILSON-COOK MEDICAL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR FUSION QUATTRO EXTRACTION BALLOON (FS-QEB-A)| OLYMPUS 180 ENDOSCOPE (UNK MODEL NUMBER)