BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER HYBRID WIRE GUIDE

    MDR report key: 1935673 · Received December 2, 2010

    Report

    Report Number
    1037905-2010-00696
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 5, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KOG
    PMA / PMN Number
    K910497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: OUR EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORT. THE OUTER BLUE COATING OF THE WIRE GUIDE HAS SEPARATED FROM THE INNER CORE WIRE NEAR THE DISTAL END, BUT THE DAMAGED SECTION OF COATING DID NOT DETACH FROM THE WIRE GUIDE. THIS DAMAGED AREA IS LOCATED APPROXIMATELY 1 CM FROM WHERE THE ORANGE AND BLUE COATING MEET (NEAR THE DISTAL END). THE COATING HAS FOLDED ONTO ITSELF EXPOSING THE INNER CORE WIRE. NO SECTION OF THE WIRE GUIDE COATING IS MISSING. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THIS OCCURRENCE WAS NOT OBSERVED. WE COULD NOT CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD OR CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER COULD NOT BE DETERMINED. 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: THE INFORMATION PROVIDED INDICATED THE ELEVATOR OF THE ENDOSCOPE WAS USED TO SECURE THE WIRE GUIDE DURING THE EXCHANGES. THIS COULD HAVE CONTRIBUTED TO THE WIRE GUIDE COATING DAMAGE. IF THE WIRE GUIDE RECEIVED EXCESSIVE PRESSURE DURING USE, PERHAPS IN RESPONSE TO RESISTANCE ENCOUNTERED, THIS COULD HAVE CONTRIBUTED TO DAMAGE OF THE WIRE GUIDE COATING. 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 AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: 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. 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 GUIDE WAS USED TO SUCCESSFULLY CANNULATE AND PERFORM EXCHANGES OF ENDOSCOPIC ACCESSORY DEVICES. THE ELEVATOR OF THE ENDOSCOPE WAS USED TO SECURE THE WIRE GUIDE DURING THE EXCHANGES. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF AN EXTRACTION BALLOON OVER THE WIRE GUIDE. THE PHYSICIAN REPORTED THAT THE DISTAL PORTION OF THE WIRE GUIDE AND THE EXTRACTION BALLOON WERE MOVING UP AND DOWN THE DUCT TOGETHER EVEN THOUGH THE WIRE GUIDE WAS BEING CONTROLLED (I.E. HELD STATIONARY) OUTSIDE OF THE ENDOSCOPE. MULTIPLE BALLOON SWEEPS WERE PERFORMED AND THE PROCEDURE WAS COMPLETED WITH THIS WIRE GUIDE. 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 TRACER HYBRID WIRE GUIDE KOG, ENDOSCOPE AND/OR ACCESSORIES KOG COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS TJF-Q180V ENDOSCOPE| CANNULA OR SPHINCTEROTOME (UNKNOWN TYPE)| COOK TRI-EX EXTRACTION BALLOON