BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3910993 · Received July 2, 2014

    Report

    Report Number
    0002090040-2014-00025
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 11, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS PHOENIX
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. THE RETURNED COMPLAINT DEVICE WAS RECEIVED OPEN WITH THE ORIGINAL STRYKER SUSTAINABILITY SOLUTIONS PACKAGING WITH EVIDENCE OF USE (BIO-BURDEN PRESENT). VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE REVEALED THE SHUNT TO BE BROKEN/TORN/SEPARATED AND THE COIL END OF SHUNT TO BE EXPOSED WITH THE COIL UNWOUND/STRETCHED. THE RESULTS OF THE INVESTIGATION PERFORMED DETERMINED THAT THE REPORTED ISSUE WAS SUBSTANTIATED. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE IS UNLIKELY TO HAVE BEEN RELEASED FROM STRYKER WITH THE REPORTED FAILURE MODE. THEREFORE, THE MOST LIKELY ROOT CAUSES ARE: MISHANDLING SUBSEQUENT TO DISTRIBUTION FROM STRYKER AND/OR AN OM DEFECT. THE DEVICE HISTORY RECORD (DHR) INDICATES THE COMPLAINT DEVICE PASSED ALL INSPECTION PRIOR TO RELEASE FROM STRYKER SUSTAINABILITY SOLUTIONS (STRYKER). THIS REPORT IS BEING FILED DUE TO THIS FAILURE BEING AN INHERENTLY DANGEROUS SITUATION. A MAUDE SEARCH REVEALED THAT THE OM OF THIS DEVICE FILES FOR THIS FAILURE ASSOCIATED WITH THESE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "A REPROCESSED AXIUS CORONARY SHUNT BROKE DURING A PROCEDURE. FORTUNATELY, THERE WAS NO PATIENT HARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385871 NA CLAMP, VASCULAR21 DXC STRYKER SUSTAINABILITY SOLUTIONS PHOENIX UNUSED 774120U

    Patients

    Seq Age Sex Outcome Treatment
    1