BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY GUIDEWIRE

    MDR report key: 2780162 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13206
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DURING A IMPLANT OF THIS LEFT VENTRICULAR LEAD, THE PHYSICIAN HAD DIFFICULTY REMOVING THIS GUIDEWIRE FROM THE BODY OF THE LEAD. THE PHYSICIAN THEREFORE ELECTED TO CUT THE TOP OF THE GUIDEWIRE, LEAVING THE BOTTOM PORTION IN THE BODY OF THE LEAD. THE LEAD WAS SUCCESSFULLY IMPLANTED AND THE POCKET CLOSED WITH THE PARTIAL GUIDEWIRE STILL IN THE BODY OF THE LEAD. NO LOT INFORMATION COULD BE OBTAINED ABOUT THE GUIDEWIRE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUITY GUIDEWIRE DQX GUIDANT PUERTO RICO BV 7081

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| S