BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACROBAT CALIBRATED TIP WIRE GUIDE

    MDR report key: 3912422 · Received May 13, 2014

    Report

    Report Number
    1037905-2014-00177
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 14, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    OCY
    PMA / PMN Number
    K122816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED 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 COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION, ALL ACROBAT CALIBRATED TIP WIRE GUIDES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. 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 REASSESS THE RISK ASSESSMENT 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. WHILE USING EXTRACTION BALLOONS AND BILIARY DILATION BALLOONS OVER THE ACROBAT WIRE GUIDE, THE COATING AT THE 25 CM MARK PULLED/ROLLED BACK, EXPOSING THE CORE WIRE. THE DEVICES WOULD NO LONGER TRAVEL OVER THE WIRE GUIDE. NO SECTION OF THE DEVICE DETACHED AND BECAME FREE INSIDE THE PATIENT. ANOTHER WIRE GUIDE 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 OCCURENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285655 ACROBAT CALIBRATED TIP WIRE GUIDE OCY, ENDOSCOPIC, GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY WILSON-COOK MEDICAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK FUSION QUATTRO EXTRACTION BALLOON (FS-QEB-A)| OLYMPUS ENDOSCOPE (UNKNOWN MODEL NUMBER)