BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 857483 · Received May 29, 2007

    Report

    Report Number
    1317056-2007-00074
    Event Type
    Death
    Date Received
    May 29, 2007
    Date of Event
    May 2, 2007
    Report Date
    May 3, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT WAS STATED THAT THE DEVICE USED IN THE REPORTED INCIDENT WILL BE RETURNED, IT HAS NOT BEEN REC'D BY THE MFR. THEREFORE, A DEVICE FAILURE ANALYSIS IS NOT YET AVAILABLE. UPON RECEIPT OF THE DEVICE/COMPLETION OF THE INVESTIGATION, A F/U MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED BY HOSPITAL, DURING A PTCA PROCEDURE, THE Y-ADAPTOR BEING UTILIZED CAME APART. THE PT HAD BEEN BROUGHT IN FROM THE ER. THE PT LATER DIED, BUT IT WAS CLEARLY STATED BY THE COMPLAINT REPORTER IN THE CARDIAC CATH LAB, AS WELL AS BY HOSPITAL PT SAFETY OFFICER THAT, THE DEATH WAS NOT DUE TO OR A COMPLICATION OF THE DEVICE MALFUNCTION. THE USED DEVICE IS BEING RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC Y-ADAPTOR DTL BOSTON SCIENTIFIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death