BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS ENDOTHERAPY DISPOSABLE GUIDEWIRE

    MDR report key: 1779248 · Received July 28, 2010

    Report

    Report Number
    9680001-2010-00004
    Event Type
    Other
    Date Received
    July 28, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 27, 2010
    Manufacturer
    ACCELLENT INC.
    Product Code
    OCY
    PMA / PMN Number
    K072354
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AND THERE WERE NO SIGNIFICANT EVENTS OR POTENTIAL ISSUES THAT COULD RESULT IN THE DETACHMENT OF THE GUIDEWIRE TIP. THERE WERE NO OTHER COMPLAINTS NOTED FOR THIS BATCH. ANALYSIS OF THE RETURNED SAMPLE INDICATED THAT THE PRODUCT MET ALL PRODUCT DIMENSIONAL REQUIREMENTS AND SPECIFICATIONS, AND THAT THE DEVICE WAS SUBJECTED TO A FORCE CAPABLE TO MODIFY THE ORIGINAL SHAPE OF THE DEVICE AND TO FORCE THE PEBAX TO SLIP OFF THE WIRE. A NEARLY IDENTICAL FAILURE MODE HAS ALSO BEEN REPORTED BY OTHER MANUFACTURERS OF SIMILAR DEVICES THAT UTILIZE SIMILAR DESIGN FEATURES. THESE INCIDENTS HAVE INVOLVED DIFFICULTY IN PASSING THE WIRE THROUGH THE CATHETER OR STENT OR REMOVING THE WIRE. THE HEALTH HAZARD ANALYSIS AND RISK ASSESSMENT BASED ON THE INFO TO DATE INDICATED THAT THE RISK OF ADVERSE OUTCOMES ASSOCIATED WITH FAILURES OF THIS TYPE IS REMOTE AND AS LOW AS REASONABLY PRACTICAL. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT WHERE DEVICE PERFORMANCE WAS LIMITED DO TO ANATOMICAL/PROCEDURAL FACTORS. FURTHER ANALYSIS IS ONGOING.

    Description of Event or Problem · 1

    DURING BILE DUCT STENT EXCHANGE, THE CUSTOMER DETECTED THE LOOSENING OF THE SHEATHING MATERIAL OF THE MOST FLEXIBLE PART OF THE GUIDE WIRE, "SO THAT THE MENTIONED MATERIAL REMAINED INSIDE THE BILE DUCT." THE USER DECIDED TO REMOVE THIS MATERIAL TOGETHER WITH THE NEXT STENT EXCHANGE, WITHIN THE NEXT 3 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ENDOTHERAPY DISPOSABLE GUIDEWIRE ERCP GUIDEWIRE OCY ACCELLENT INC. GV230-3527S 680892

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention