BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORONARY GUIDING CATHETER

    MDR report key: 43810 · Received October 16, 1996

    Report

    Report Number
    2027891-1996-00001
    Event Type
    Death
    Date Received
    October 16, 1996
    Date of Event
    June 14, 1996
    Report Date
    September 19, 1996
    Manufacturer
    DEVICES FOR VASCULAR INTERVENTION, INC
    Product Code
    DYB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A DCA PROCEDURE, A DISSECTION HAD OCCURRED IN THE PT'S LEFT MAIN. THE PT WAS SENT TO SURGERY AND WAS INITIALLY REPORTED AS HIGH-RISK. THE PT SUBSEQUENTLY EXPIRED ONE MONTH POST-OP. DISSECTION HAD OCCURRED 48 HOURS POST MI IN A HIGH RISK PTCA. PHYSICIAN DID NOT INDICATE WHAT DEVICE CONTRIBUTED TO DISSECTION. IT IS UNKNOWN IF A DEVICE MALFUNCTION HAD OCCURRED. THE DEVICE WAS DISCARDED BY THE ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORONARY GUIDING CATHETER GUIDING CATHETER DYB DEVICES FOR VASCULAR INTERVENTION, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death