BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    MDR report key: 3250497 · Received July 23, 2013

    Report

    Report Number
    1820334-2013-00284
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 24, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO ASSIST IN THE INVESTIGATION. PER QUALITY CONTROL SPECIFICATIONS, "CONFIRM SURFACE OF SHEATH IS FREE OF EXCESSIVE DENTS, BUMPS OR SCRATCHES." IN ADDITION, THE INSTRUCTIONS FOR USE CAUTIONS THE END USER, "ALL CATHETERS AND INSTRUMENTS USED WITH THIS INTRODUCER SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. SEPARATION OF THE SHEATH MAY RESULT WHEN THE FIT IS TIGHT." AS WELL AS THE WARNING, "BEFORE WITHDRAWING THE SHEATH THROUGH TORTUOUS ANATOMY, INSERT THE INTRODUCER DILATOR TO AVOID POSSIBLE BREAKAGE." WITHOUT BENEFIT OF EXAMINING THE COMPLAINT DEVICE, IT IS DIFFICULT TO DETERMINE WITH ANY CERTAINTY WHY THIS FAILURE MODE OCCURRED. ALTHOUGH 100% OF THESE DEVICES ARE INSPECTED BY QUALITY CONTROL FOR SURFACE INTEGRITY, THE SHEATH WAS REPORTED TO HAVE SEPARATED. WITHOUT BENEFIT OF EXAMINING THE COMPLAINT DEVICE, IT IS DIFFICULT TO DETERMINE WITH ANY CERTAINTY WHY THIS FAILURE MODE OCCURRED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE ARE CONTINUING TO MONITOR COMPLAINTS FOR SIMILAR EVENTS. PER QUALITY ENGINEERING RISK ASSESSMENT, THERE IS INSUFFICIENT RISK TO REQUIRE ADDITIONAL CORRECTIVE ACTIONS AT THIS TIME.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341901 FLEXOR SHUTTLE TIBIAL GUIDING SHEATH DYB COOK, INC. NA 2880236

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR