BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERCP GUIDE WIRE

    MDR report key: 1743568 · Received June 24, 2010

    Report

    Report Number
    9680001-2010-00003
    Event Type
    Other
    Date Received
    June 24, 2010
    Date of Event
    May 25, 2010
    Report Date
    June 21, 2010
    Manufacturer
    ACCELLENT INC
    Product Code
    OCY
    PMA / PMN Number
    K072354
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING BATCH (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. WE ARE INITIATING AN IN-DEPTH INVESTIGATION, INCLUDING SHORT AND LONG TERM CORRECTIVE AND PREVENTIVE ACTIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS.

    Description of Event or Problem · 1

    BILE DUCT STRICTURE-PROCEDURE WAS TO EXCHANGE 7FR DOUBLE PIGTAIL STENT. ON WITHDRAWAL OF THE WIRE THE HYDROPHILIC RADIOPAQUE TIP DETACHED FROM THE REST OF THE WIRE AND WAS LEFT IN THE BILE DUCT. REMOVAL WAS DONE WITH THE USE OF A RETRIEVAL BASKET. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERCP GUIDE WIRE ERCP GUIDE WIRE OCY ACCELLENT INC G-V230-3545S 690977

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention