BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT CALIBRATED TIP WIRE

    MDR report key: 4223590 · Received August 5, 2014

    Report

    Report Number
    1037905-2014-00315
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 8, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    OCY
    PMA / PMN Number
    K122816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: OUR EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORT. APPROXIMATELY 13.5 CM FROM THE DISTAL END IS A 5 CM SECTION OF EXPOSED CORE WIRE. THE COATING HAS ROLLED OVER ITSELF TOWARDS THE DISTAL END. THERE IS A SECTION OF FRAYED COVERING APPROXIMATELY 2 CM LONG HANGING FROM THE ROLLED UP SECTION. DUE TO THE CONDITION OF THE RETURNED DEVICE IT CANNOT BE DETERMINED IF PART OF THE DEVICE IS MISSING. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY 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 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 NOTES FOR BEST RESULTS, WIRE GUIDE SHOULD BE KEPT WET. ALSO, USE OF THIS WIRE WITH METAL TIP ERCP DEVICES MAY RESULT IN DAMAGE TO THE EXTERNAL COATING AND/OR TIP OF THE WIRE GUIDE. PRIOR TO DISTRIBUTION, ALL COOK ACROBAT CALIBRATED TIP WIRE GUIDES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. 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 REASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK ACROBAT CALIBRATED TIP WIRE GUIDE. THE COATING STARTED TO PEEL APART FROM THE WIRE AFTER 3 EXCHANGES. NO SECTION OF THE DEVICE DETACHED AND BECAME FREE INSIDE OF THE PATIENT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. 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
    458632 ACROBAT CALIBRATED TIP WIRE OCY, ENDODSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY WILSON-COOK MEDICAL INC W3291717

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ENDOSCOPE (UNKNOWN MODEL NUMBER),| COOK FUSION OMNI-TOME SPHINCTEROTOME