BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1040636 · Received May 8, 2008

    Report

    Report Number
    2134265-2008-01330
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE BALLOON CATHETER WAS DISPOSED AT THE USER FACILITY; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING OVER-THE-WIRE DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 11512133

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE V-18| MEDIKIT 6F