BEUDAMED
    FDA Adverse Event Death Summary report: N

    HI-TORQUE FLOPPY EXTRA SUPPORT GUIDEWIRE

    MDR report key: 37491 · Received September 5, 1996

    Report

    Report Number
    2024168-1996-00001
    Event Type
    Death
    Date Received
    September 5, 1996
    Report Date
    September 5, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN SECTION F WAS COMPLETED BY THE MFR. DURING PROCESSING OF THIS COMPLAINT QA ATTEMPTED TO OBTAIN COMPLETE INFO OF THE EVENT AND PATIENT STATUS FROM A HOSPITAL OR FIELD CONTACT.

    Description of Event or Problem · 1

    DURING A PTCA OF THE CIRCUMFLEX ARTERY, THE TIP OF THE GUIDEWIRE DETACHED AND REMAINED IN THE PT. THE PT WAS NOT SENT TO SURGERY INITIALLY. BUT IN RECOVERY THE PT DEVELOPED CARDIAC TAMPONADE AND WAS SENT TO EMERGENCY SURGERY. THE PT EXPIRED POST OPERATIVELY. THE ACCOUNT INDICATED THAT THE TIP OF THE GUIDEWIRE LIKELY HAD BECOME EMBEDDED INTO THE VESSEL WALL AND DETACHED WHILE REMOVING THE FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE FLOPPY EXTRA SUPPORT GUIDEWIRE GUIDEWIRE DQX ADVANCED CARDIOVASCULAR SYSTEMS, INC. NA 6051451

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death