BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACER METRO DIRECT WIRE GUIDE

    MDR report key: 3063300 · Received April 11, 2013

    Report

    Report Number
    1037905-2013-00145
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 14, 2013
    Manufacturer
    WILSON COOK MEDICAL INC
    Product Code
    KOG
    PMA / PMN Number
    K910497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: OUR EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORT. THE WIRE GUIDE WAS DAMAGED AND THE COIL SPRING TIP WAS CUT OFF AND WAS NOT RETURNED WITH THE DEVICE. ACCORDING TO THE REPORT THE WIRE GUIDE WAS CUT. THE WIRE GUIDE WAS RETURNED IN TWO SEPARATE SECTIONS. SECTION ONE WAS APPROX. 125.3 CM LONG AND SOME OF THE COATING WAS BUNCHED AND APPROX 2CM OF THE CORE WIRE WAS EXPOSED. THE SECOND SECTION WAS APPROX. 472.0 CM LONG AND WAS DAMAGED IN MULTIPLE PLACES ALONG THE LENGTH AND HAD MULTIPLE PLACES WERE THE CORE WIRE WAS EXPOSED. THERE WERE SEVERAL SMALL, LESS THAN 1CM, SECTIONS OF THE COATING THAT HAD PEELED AND WERE MISSING. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LAB ANALYSIS. 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. INVESTIGATION CONCLUSIONS: 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 PATIENT 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. ACCORDING TO THE REPORT THE WIRE WAS CUT WHERE IT WAS FRAYED AND THE PHYSICIAN USED THE REMAINING PORTION TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTY. THE INSTRUCTIONS FOR USE STATES 'VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.' A POSSIBLE CONTRIBUTING FACTOR TO DAMAGE TO THE WIRE GUIDE IS USE OF THE WIRE GUIDE WITH METAL TIP ERCP DEVICES. THE INSTRUCTIONS FOR USE CAUTION THE USER THAT USE OF METAL TIP ERCP DEVICES MAY RESULT IN DAMAGE TO THE EXTERNAL COATING AND/OR TIP OF THE WIRE GUIDE. PRIOR TO DISTRIBUTION, ALL TRACER METRO DIRECT 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: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED REMOTE. 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

    THE FOLLOWING INFO WAS INITIALLY PROVIDED TO COOK: THE OUTSIDE COATING FRAYED IN SEVERAL LOCATIONS. NOTHING DETACHED IN PATIENT. THE WIRE WAS CUT WHERE IT WAS FRAYED AND THEN PHYSICIAN USED THE REMAINING PORTION TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTY. THIS DID NOT REASONABLY SUGGEST A REPORTED EVENT HAD OCCURRED. OUR EVAL OF THE RETURNED DEVICE CONFIRMED THAT THE DISTAL TIP OF THE DEVICE HAD BEEN CUT AND WAS NOT INCLUDED IN THE RETURN. BECAUSE THE INITIAL REPORTER STATED THE FRAYED COATING HAD BEEN CUT FROM THE DEVICE, THIS REASONABLY SUGGESTS THE COATING OF THE WIRE GUIDE TIP WAS DAMAGED. THIS HAS BEEN ESTABLISHED AS A REPORTABLE OCCURRENCE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADD'L 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
    154592 TRACER METRO DIRECT WIRE GUIDE KOG, ENDOSCOPE AND OR ACCESSORIES KOG WILSON COOK MEDICAL INC W3235215

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS SINGLE BALLOON ENDOSCOPE