BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER METRO DIRECT WIRE GUIDE

    MDR report key: 2062180 · Received March 18, 2011

    Report

    Report Number
    1037905-2011-00172
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Report Date
    December 18, 2010
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KOG
    PMA / PMN Number
    K910497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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). (B)(4). EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD AND SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER INVOLVED 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 INFO PROVIDED INDICATED THE ACCESSORY DEVICE USED WITH THIS WIRE GUIDE HAS A METAL TIP. THIS IS THE CAUSE FOR THIS OCCURRENCE. THE INSTRUCTIONS FOR USE CAUTION THE USER THAT USE OF THIS WIRE GUIDE WITH METAL TIP ERCP DEVICES MAY RESULT IN DAMAGE TO THE EXTERNAL COATING AND/OR TIP OF THE WIRE GUIDE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO EXCHANGE COMPATIBLE WIRE-GUIDED ACCESSORIES OVER THE WIRE GUIDE. IF THESE INSTRUCTIONS ARE NOT FOLLOWED, THIS CAN CONTRIBUTE TO THIS OCCURRENCE. PRIOR TO DISTRIBUTION, ALL TRACER METRO DIRECT WIRE GUIDES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED AND THE INFO PROVIDED INDICATED THE PRODUCT WAS USED IN CONTRADICTION WITH THE INTENDED USE LISTED IN THE INSTRUCTIONS FOR USE. THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. 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 ENDOSCOPIC DRAINAGE OF A CYST, THE PHYSICIAN USED A COOK TRACER METRO DIRECT WIRE GUIDE WITH A COOK ECHOTIP ULTRA ULTRASOUND ACCESS NEEDLE. DURING USE, A SECTION OF THE WIRE GUIDE COATING PEELED AWAY FROM THE WIRE GUIDE INTO THE STOMACH. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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 METRO DIRECT WIRE GUIDE KOG, ENDOSCOPE AND/OR ACCESSORIES KOG WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK ECHO-HD-19-A| OLYMPUS GFUCT-140 ENDOSCOPE