BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXTRA S'PORT WIRE

    MDR report key: 33363 · Received June 11, 1996

    Report

    Report Number
    MW1009267
    Event Type
    Death
    Date Received
    June 11, 1996
    Date of Event
    May 22, 1996
    Report Date
    June 6, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FRACTURED WIRE DURING PTCA AND CORONARY STENT PROCEDURE 5/22/96. DISSECTION OF PROX LAD. CATH LAB RN NOT AWARE TILL FILM REVIEWED NEXT DAY. THEREFORE WIRE NOT SAVED, CONTAMINATED AND DISCARDED. INFORMED CARDIOVASCULAR SURGEON. PT TO OR FOR CABG. WIRE NOT REMOVED IN SURGERY, BYPASS GRAFT DONE. PT EXPIRED 5/26 IN CRITCARE UNIT POST CABG. PT JEHOVAH'S WITNESS AND REFUSED BLOOD TRANSFUSION AND EXPIRED POST SURGERY. NO AUTOPSY AND WIRETIP NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRA S'PORT WIRE CORONARY GUIDE WIRE DQX ADVANCED CARDIOVASCULAR SYSTEMS, INC. .014 5120951

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| R