BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER HYBRID WIRE GUIDE

    MDR report key: 1930002 · Received November 19, 2010

    Report

    Report Number
    1037905-2010-00637
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 22, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KOG
    PMA / PMN Number
    K910497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED TO US BY THE COOK FACILITY IN (B)(4) ON BEHALF OF A MEDICAL FACILITY IN (B)(6). EVALUATION: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVALUATION. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. THE INTENDED USE LISTED IN THE INSTRUCTIONS FOR USE INDICATES THIS DEVICE IS USED TO ASSIST IN CANNULATION OF THE BILIARY AND PANCREATIC DUCTS AND TO AID IN BRIDGING DIFFICULT STRICTURES DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). IF THE WIRE GUIDE RECEIVED EXCESSIVE PRESSURE IN RESPONSE TO RESISTANCE DUE TO A SEVERE STRICTURE, THIS COULD HAVE CONTRIBUTED TO SEPARATION OF THE WIRE GUIDE COATING TIP. THE INSTRUCTIONS ADVISE THE USER THAT THE WIRE GUIDE SHOULD BE KEPT WET FOR BEST RESULTS. THE INSTRUCTIONS FOR USE DESCRIBE THE APPROPRIATE FLUSHING TECHNIQUES FOR USE OF THIS COATED WIRE GUIDE. THESE TECHNIQUES DESCRIBED INCLUDE FLUSHING THE WIRE GUIDE HOLDER WITH 30CC OF STERILE WATER PRIOR TO REMOVING THE WIRE GUIDE FROM THE HOLDER, FLUSHING THE ENDOSCOPE ACCESSORY CHANNEL AND/OR LUMEN OF ACCESSORY DEVICE WITH STERILE WATER BEFORE WIRE GUIDE INSERTION. IF THESE FLUSHING TECHNIQUES ARE NOT FOLLOWED OR INADEQUATE FLUSHING OCCURS, THIS CAN CONTRIBUTE TO WIRE GUIDE COATING SEPARATION. IF THE ENDOSCOPE OR ACCESSORY DEVICE USED WITH THIS DEVICE CONTAINS A BURR, THIS COULD CONTRIBUTE TO WIRE GUIDE COATING SEPARATION. 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 ACTIONS: A CORRECTIVE ACTION HAS BEEN INITIATED IN AN EFFORT TO REDUCE OCCURRENCES OF THIS NATURE. THIS PRODUCT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. NO FURTHER ACTION WARRANTED AT THIS TIME BECAUSE THIS REPORT COULD NOT BE VERIFIED. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ENDOSCOPY TRACER HYBRID WIRE GUIDE. THE WIRE WAS PLACED THROUGH AN ACCESSORY DEVICE AND INTO THE COMMON BILE DUCT. THE COATING OF THE WIRE GUIDE STRIPPED, EXPOSING THE INNER CORE WIRE. THE WIRE GUIDE AND ACCESSORY DEVICE WERE REMOVED FROM THE ENDOSCOPE AND ANOTHER DEVICE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACER HYBRID WIRE GUIDE KOG, ENDOSCOPE AND/OR ACCESSORIES KOG COOK ENDOSCOPY W2854694

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR COOK PC-5 PUSHING CATHETER| COOK GT-1-UT ERCP CATHETER| COOK SPSOF-5-4 PLASTIC STENT| COOK GT-1 ERCP CATHETER| BOSTON SCIENTIFIC RX-4X5 BALLOON| ENDOSCOPE (UNKNOWN TYPE)