BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHISPER VIEW

    MDR report key: 3912615 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-12071
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 2, 2014
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS GUIDE WIRE WAS FRACTURED AND A PART WAS LEFT IN THE PATIENT. THE SURGEON OPTED TO LEAVE THE WIRE BECAUSE IT WAS DIFFICULT TO REMOVE DUE TO PATIENT ANATOMY. THE SURGEON PLACED THE LEAD OVER THE GUIDE WIRE. USE AS IS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390578 WHISPER VIEW GUIDE WIRE DQX EXTERNAL MANUFACTURER 4648

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R