BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACC10S

    MDR report key: 863024 · Received June 7, 2007

    Report

    Report Number
    2026095-2007-00030
    Event Type
    Malfunction
    Date Received
    June 7, 2007
    Date of Event
    September 5, 2006
    Report Date
    June 1, 2007
    Manufacturer
    I-FLOW CORP.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: WE HAVE NOT RECEIVED THE ACTUAL DEVICE INVOLVED IN THIS INCIDENT. WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. HOWEVER, WE PERFORMED VISUAL AND DIMENSIONAL INSPECTIONS ON THREE RETAINED DEVICES HAVING THE SAME LOT (6B2691) INVOLVED IN THIS INCIDENT. VISUAL INSPECTION DID NOT REVEAL ANY DEFECT ON THE SHEATHS. THE INTERNAL AND EXTERNAL DIAMETERS OF THE SHEATHS WERE MEASURED AND FOUND TO BE WITHIN THE LIMITS. CURRENTLY, I-FLOW CORPORATION IS CONDUCTING AN INVESTIGATION ON THE SHEATH MATERIAL TO IDENTIFY THE ROOT CAUSE OF SHEATH BREAKAGES. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    POST SPINAL HARDWARE REMOVAL, PERFORMED IN 2006, THE INTRODUCER SHEATH BROKE INSIDE THE PATIENT WHILE BEING REMOVED. THE SHEATH BROKE FOUR INCHES FROM THE TIP THUS LEAVING AN APPROXIMATE FOUR INCHES INSIDE THE PATIENT. THE REMNANT SEGMENT WAS DISCOVERED DURING ANOTHER SURGICAL PROCEDURE, IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACC10S SHEATH, TUNNELER INTRODUCER DYB I-FLOW CORP. 5001529 6B2691

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other