BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F ARCHER JR4.0SH

    MDR report key: 224005 · Received May 13, 1999

    Report

    Report Number
    1220452-1999-00006
    Event Type
    Malfunction
    Date Received
    May 13, 1999
    Date of Event
    February 18, 1999
    Report Date
    May 11, 1999
    Manufacturer
    MEDTRONIC INTERVENTIONAL VASCULAR, INC.
    Product Code
    DQX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO THE MFR THAT A .035 J WIRE (GUIDE WIRE) PUNCTURED THROUGH THE SECONDARY CURVE OF THE GUIDE DURING THE PROCEDURE. NO PT INJURY WAS REPORTED. THE DEVICE HAS NOT BEEN RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ARCHER JR4.0SH GUIDING CATHETER DQX MEDTRONIC INTERVENTIONAL VASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN