BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUIDANT ABBOTT IRON MAN GUIDE WIRE 300 CM

    MDR report key: 1210785 · Received October 21, 2008

    Report

    Report Number
    1210785
    Event Type
    Death
    Date Received
    October 21, 2008
    Date of Event
    August 7, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT THE CONCLUSION OF THE PCI PROCEDURE, UNABLE TO REMOVE INTERVENTIONAL GUIDE WIRE FROM THE PROXIMAL LAD STENTS. THE GUIDE WIRE WAS LEFT IN AND THE PT WENT TO THE OR. THE WIRE WAS CLIPPED, A SMALL PIECE WAS LEFT IN THE LM AND PROXIMAL LAD, THE REST WAS REMOVED. THE PT UNDERWENT BYPASS TO THE LAD. THE COMPANY WAS INFORMED OF INCIDENT. THE PT WAS SUBSEQUENTLY TRANSFERRED TO MONTEFIORE. THE INCIDENT HAS ALREADY BEEN VOLUNTARILY REPORTED TO THE MANUFACTURER THE DAY AFTER THE INCIDENT. THE MANDATORY REPORT WAS DELAYED IN TRYING TO LEARN THE PT OUTCOME. WE HAVE SUBSEQUENTLY LEARNED THAT THE PT EXPIRED. EXACT DATE AND TIME OF DEATH IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT ABBOTT IRON MAN GUIDE WIRE 300 CM IRON MAN GUIDE WIRE DQX ABBOTT VASCULAR 0.014" 300 CM 7070291

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R