BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS S'PORT GUIDE WIRE SYSTEM

    MDR report key: 40549 · Received September 30, 1996

    Report

    Report Number
    2024168-1996-00013
    Event Type
    Injury
    Date Received
    September 30, 1996
    Date of Event
    August 28, 1996
    Report Date
    September 27, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PTCA/STENT PROCEDURE, WHILE REMOVING THE GUIDEWIRE FROM THE PT, THE GUIDEWIRE TIP FRACTURED. THE PHYSICIAN ATTEMPTED TO RETRIEVE GUIDEWIRE FRAGMENT FOR 3 1/2 HRS IN CARDIAC CATH LAB BUT WAS UNSUCCESSFUL. THE PT WAS SENT TO BYPASS SURGERY AND FOR REMOVAL OF THE GUIDEWIRE FRAGMENT. THE PT IS REPORTED AS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS S'PORT GUIDE WIRE SYSTEM GUIDE WIRE SYSTEM DQX ADVANCED CARDIOVASCULAR SYSTEMS, INC. NA 6022751

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R SURGERY TO REMOVE FRACTURED WIRE AND CORONARY ARTY| BYPASS GRAFTING, DONE EMERGENTLY.