BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GT Z FUSION

    MDR report key: 344026 · Received July 23, 2001

    Report

    Report Number
    344026
    Event Type
    Injury
    Date Received
    July 23, 2001
    Date of Event
    July 18, 2001
    Report Date
    July 20, 2001
    Manufacturer
    MEDTRONIC AVE
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PRODUCT INSERTED INTO RIGHT ARM FOR AV GRAFT. POST PROCEDURE, UPON REMOVAL OF WIRE, WIRE BROKE IN RIGHT ARM-TRIED TO RETRIEVE WIRE THROUGH RIGHT ARM TO NO AVAIL, TRIED TO RETRIEVE THROUGH GROIN TO NO AVAIL. DURING RETRIEVAL PROCEDURE, PT SUFFERED A STROKE. STARTED ON TPA AND REPRO WITH GREAT RESULTS. TRANSFERRED TO ICU. FEW HOURS LATER, PT DETERIORATED CT REVEALED LARGE BLEED TO HEAD TRANSFERRED TO ANOTHER FACILITY FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33086 GT Z FUSION STEERABLE GUIDE WIRE DQX MEDTRONIC AVE NTLPLS180 25258

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening