BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERCP GUIDE WIRE

    MDR report key: 1743570 · Received June 24, 2010

    Report

    Report Number
    9680001-2010-00002
    Event Type
    Other
    Date Received
    June 24, 2010
    Date of Event
    May 13, 2010
    Report Date
    June 21, 2010
    Manufacturer
    ACCELLENT INC
    Product Code
    OCY
    PMA / PMN Number
    K072354
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF MANUFACTURING RECORDS FOR THE TIME PERIOD REVEALED NO SIGNIFICANT EVENTS OR POTENTIAL ISSUES THAT COULD RESULT IN THE DETACHMENT OF THE GUIDEWIRE TIP. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICES MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. FURTHER ANALYSIS IS ONGOING.

    Description of Event or Problem · 1

    DURING AN ERCP TO REMOVE STONES FROM THE CBD (COMMON BILE DUCT) A SPHINCTEROTOME WAS USED TO CANNULATE FOLLOWED BY A BALLOON TO TRAWL THE DUCT FOR STONES. AFTER THE STONE WAS REMOVED, A FURTHER X-RAY WAS TAKEN WHICH REVEALED THAT THE TIP OF THE WIRE HAD BECOME DETACHED AND WAS LEFT IN THE LOWER CBD. THE CONSULTANT BELIEVES THAT THE TIP MAY HAVE BECOME DETACHED DURING THE TRAWL FOR STONES AS IT WAS A DIFFICULT TRAWL. THE TIP WAS REMOVED USING A BALLOON AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. NO PRODUCT WAS RETAINED BY THE HOSPITAL FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERCP GUIDE WIRE ERCP GUIDE WIRE OCY ACCELLENT INC G-V230-3527S

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention